• Implements and sustains a comprehensive quality assurance and patient safety programs.
• Leads, develops and manages strategies for measurement aligned with external and internal benchmarks and standards of quality, patient safety, patient experience and risk management.
• Aligns activities, policies, process guidance and analysis (measurement, review, examination) with accreditation standards for quality, patient safety, patient experience, and risk management defined by TJC and AAAHC and industry recognized best practices from reputable sources.
• Develops work plans and performance evaluation criteria; ensures subordinates achieve Agency goals. Provides management direction and leadership under the general direction of the Office Director. Provides leadership, guidance, and direction for the IHS programs supporting and ensuring quality assurance, compliance, patient safety, and risk management. Formulates budget requests and develops related supporting justification narratives to meet program objectives of ensuring consistently high quality in all IHS clinical operations.
• Plans work to be accomplished by subordinates, set and adjust short-term priorities, and prepare schedules for completion of work; Assigns work to subordinates based on priorities, selective consideration of the difficulty and requirements of assignments, and the capabilities of employees; Evaluate work performance of subordinates; Gives advice, counsel, or instruction to employees, and refers group grievances and more serious unresolved complaints to a higher-level supervisor or manager; Interviews candidates for positions in the unit; recommends appointment, promotion, or reassignment; Hears and resolves complaints from employees, refers group grievances and more serious unresolved complaints to a higher-level supervisor or manager; Effects minor disciplinary measure of warnings and reprimands, and recommends other action in more serious cases; Identifies
  developmental and training needs of employees, provides or arranges for needed development and training; Finds ways to improve

Starting at $163,964 Per Year (GS 15)

Your new company
Hays have been exclusively retained by an extremely well-funded biotech driving breakthrough innovations in the space of gene therapy.They have developed an innovative new technology that allows them to deliver gene therapies in a novel way to patients with rare diseases and are currently going into their initial clinical trial to validate its use. Alongside this they have multiple other programmes approaching the clinic and several more in development, giving them a very strong pipeline.The company prides itself on innovation and collaborative work and has a very experienced senior leadership & technical team coupled with a C-suite with a truly impressive track record.
They are looking to add a Director / Senior Director of Process and Compliance to help them move the company's Clinical Technologies forward and are offering an excellent package plus significant remote working flexibility and the chance to make a real impact.


Your new role
This is a permanent position, working closely with the CEO, VP Biometrics and other senior stakeholders to ensure clinical (and potentially other, earlier discovery) technologies remain compliant with regulatory requirements as well as driving innovation within this space, eg through the adoption of new processes/technologies/software, etc.The company is ideally looking for candidates to spend some time in office, but the exact amount is open for discussion dependent on candidate location and other factors.
Major responsibilities will include a mix of (but aren't limited to):

• Establish the implementation roadmap for all clinical technologies that enable clinical trial management and data collection mechanisms
• Develop, manage and implement processes for clinical technology adoption and management, eg software solutions
• Drive new technology solutions for site visits, clinical monitoring, risk management and provide clinical operations colleagues with innovative ways to make a broader impact on the lives of the patients in our studies
• Oversee / manage projects to integrate and implement new technologies within clinical data capture or similar
• Manage the creation of new - and optimisation of existing - quality management processes
• Liaise with colleagues, eg within IT, Clinical Operations, Biometrics, QA & Regulatory Affairs, to ensure clinical trial activities are properly integrated / aligned to protocols
• Manage, implement, and develop solutions in site start-up, study recruitment/conduct, and data capture processes across multiple clinical technology programmes
• Act as a technical expert and leader within the business
• Drive best practice within the business

What you'll need to succeed
As well as strong communication skills for dealing with collaborators, stakeholders and vendors/CROs, you should have:

• A BSc (or equivalent experience) in a discipline such as computer science, biometrics, statistics, IT, or a life sciences discipline such as chemistry, biochemistry or biology
• Experience of the clinical drug development environment including experience in clinical software development and application deployment is essential, whether from a QA/CSV standpoint, or the data management/clinical operations side
• Deep expertise of regulatory requirements and industry standards relevant to clinical research, ensuring compliance throughout all stages of clinical trials
• Proven ability to design and/or develop technology solutions deployed in clinical trials - such as CTMS or other relevant technologies

Familiarity with navigating the clinical trial lifecycle and adhering to 21-CFR Part 11 regulations and validation processes

• Well-versed in the utilisation of common tools and technologies within clinical trials, including TMF, CTMS, DCT, and eSource, EDC, etc
• The ability to manage multiple concurrent projects and effectively prioritise between competing requirements

Experience of rare disease / small cohort trials would be an advantage, but is not necessary for this role.


What you'll get in return
You'll get the chance to make a significant impact on the company's clinical development and R&D/discovery projects, taking on project leadership for a number of different aspects, driving the adoption of new protocols and processes to make their operations as innovative and effective as possible whilst maintaining compliance with regulatory standards.The company are very flexible on salary bands and package depending on the skills of the person coming in and you will be a key member of a highly experienced team, with direct access to the C-suite leadership.


What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call me on 0203 465 0057.If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career, especially as there are a number of other bioinformatics, data science and statistics positions available.

Keywords: clinical, data, management, manager, quality, systems, process, compliance, controls, tools, CSV, validation, regulatory, compliance, computer, systems, SDTM, ADAM, CDISC, SAS, Snowflake, QA, audit, 21-CFR Part 11, Director, VP, drug, development, R&D, discovery, IT, pharmaceutical, biotech, operations

The Director of Compliance will be responsible for oversight of all quality assurance operations related to the ORR Call Center and execution of project deliverables. The position will act as a member of the leadership team to recommend technological solutions to building awareness, knowledge, and skill; project manage training and reporting deliverables, and will report to the Project Director for the Call Center. 

Key Responsibilities:  

• Oversee and manage the following: 
• Design and operate quality control measures for call center and program oversight.  
• Ensure accuracy and timeliness in execution of all training, QA, and reporting project deliverables.  
• Provide direct oversight of all work streams related to training, QA, and reporting project deliverables. 
• Work closely with the call center staff, ORR (client) and client’s stakeholders in the execution of deliverables and services.  
• Ensure timely and accurate communication with client to ensure transparency and communication of medium and long-term project activities, outstanding issues, and risk mitigation. 
• Enforce uniform development and quality standards and ensure accuracy of project deliverables. 
• Develop monthly reports using available data 
• Directly supervise all subject matter experts in the development of training, FRA/SWB Supervisor and the QA Manager 
• Analyze data collection instruments, tools, and systems to ensure effectiveness and determine when necessary to update or expand systems to provide robust data to the client.  
• Work with clients and SMEs to perform needs assessments to identify critical knowledge, skills, and behaviors; produce gap analyses; and recommend appropriate learning strategies for call center employees 
• Assure all annual and monthly reports are of high quality and delivered according to contract deliverable schedule 

Basic Qualifications:  

• Masters in social services: a Bachelor’s in the same field can be substituted for the MS/MA if accompanied by a minimum of 8 years of training development work in the field of refugee resettlement 
• 3-5 years managing projects or equivalent of project management such as managing multiple aspects of deliverables, deadlines, and partner relationships  
• Minimum of 5 years experience in determining quality of services 
• Minimum of 5 years experience working with a federal client relationship  
• Active Tier 2 security clearance per contract requirements

Preferred Skills/Experience:  

• Experience conducting detailed training and/or job/task analyses  
• Experience developing both soft-skills and technical training  
• Experience with Office of Refugee Resettlement 
• Experience in a Quality Assurance or Continuous Quality Assurance position 
• Experience interacting with and advising clients  

  

Professional Skills:  

• Strong project management skills 
• Strong oral and written communication skills  
• Strong analytical, problem-solving, and decision making capabilities  
• Strong attention to detail  
• Ability to multi-task in a fast-paced environment  
• Ability to work well both individually and in a team environment  
• Ability to prioritize multiple tasks while demonstrating the initiative to complete projects with minimum supervision  
• Ability to work with all levels of internal staff, as well as outside clients and vendors  
• Ability to be flexible to handle multiple priorities and to work limited overtime as necessary  
• Ability to travel up to 25%  
• Proficiency in MS Office Applications (Word, PowerPoint, Outlook, Excel, Project) and MS SharePoint  

  

ICF offers an excellent benefits package, an award-winning talent development program, and fosters a highly skilled, energized and empowered workforce. 

Working at ICF

ICF is a global advisory and technology services provider, but we’re not your typical consultants. We combine unmatched expertise with cutting-edge technology to help clients solve their most complex challenges, navigate change, and shape the future.

We can only solve the world's toughest challenges by building an inclusive workplace that allows everyone to thrive. We are an equal opportunity employer, committed to hiring regardless of any protected characteristic, such as race, ethnicity, national origin, color, sex, gender identity/expression, sexual orientation, religion, age, disability status, or military/veteran status. Together, our employees are empowered to share their expertise and collaborate with others to achieve personal and professional goals. For more information, please read our EEO & AA policy.

Reasonable Accommodations are available, including, but not limited to, for disabled veterans, individuals with disabilities, and individuals with sincerely held religious beliefs, in all phases of the application and employment process. To request an accommodation please email icfcareercenter@icf.com and we will be happy to assist. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations.

Read more about workplace discrimination rights, the Pay Transparency Statement, or our benefit offerings which are included in the Transparency in (Benefits) Coverage Act.

 

Pay Range - There are multiple factors that are considered in determining final pay for a position, including, but not limited to, relevant work experience, skills, certifications and competencies that align to the specified role, geographic location, education and certifications as well as contract provisions regarding labor categories that are specific to the position. The pay range for this position is:

$92,986.00 - $158,076.00

Nationwide Remote Office (US99)

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com

Our search for better is changing the lives of our customers. It’s changing the careers of our people too –creating new challenges and opportunities all the time. We’re a business that never stands still. Join us on our journey to #ForeverCaring as a Senior Director, Quality (Complaint Handling and Post Market Surveillance), and you won’t either.

 

This is a key role within the Global Quality function, driving a high-performance culture and setting the standard for Quality Excellence. We are seeking a transformative thinker and diligent executor to help improve the operational execution of Complaints & Post Market Surveillance.

The Senior Director, Quality (Complaint Handling/PMS) will be accountable for the global complaint handling and post market surveillance process for the entire business, inclusive of all business units.  You will partner with the business for timely execution of complaint investigations to enable robust feedback from our customers.  You will develop and lead a team that reviews, processes and analyzes complaints data into practical business terms to ensure proper prioritization of initiatives to improve the customer experience and deliver on our forever caring promise.  This strategic partner will collaborate with the commercial organization to ensure all channels for reporting complaints are efficient and integrated, providing them with real-time complaints progress & feedback. 

Your Accountabilities and Responsibilities:

• Define global strategy for complaint handling and post market surveillance across Convatec. 
• Turn complex complaints data/information into practical analytics to facilitate business decisions. 
• Lead, mentor, coach, and develop complaint handling and post market surveillance teams.
• Partner with business unit (BU) leaders with an emphasis in manufacturing site collaboration in BU specific complaint analysis, ensuring the right focus/actions are placed in the main areas of opportunity/concern.
• Establish clear roles & responsibilities when liaising with legal, medical, quality, regulatory, operations, engineering, and other functions in the complaint handling and post market surveillance processes.
• Own  dashboard of performance related to complaint handling and post market surveillance activities.
• Develop strategy that drives improvements in the customer experience and facilitates how customer complaints are collected throughout the world.
• Harmonize & connects global processes for efficiency.
• Define strategy with commercial on how we gather & analyze feedback from social platforms and other media streams.
• Acts as the main point of contact for complaint handling - including complaint processing, investigation, and timely closure.
• Integrate data analytics into established power BI dashboards to enable one source of truth.
• Partner with R&D (Technology & Innovation) to ensure design related complaints have a clear funnel for investigations. 
• Integrate technology into repetitive tasks, to optimize speed of processing and focus on clarity of analytics for signals & corresponding actions.
• Drive continuous improvement in corresponding processes & tools.
• Identify, hire, train, develop and maintain qualified Quality personnel to support the Quality plans, objectives and goals.

 

The Ideal Candidate should bring the following qualities to the role:

• Minimum of B.S., or equivalent, in a scientific/technical discipline is required.  Advanced degree (M.S., M.B.A, Ph.D. or equivalent) preferred.
• Experience working in an international environment in a global position is required.
• Certifications in Quality Management Systems preferred.
• (5-7) years in the medical device and/or pharmaceutical industry.
• Five to seven (5-7) years’ experience in a leadership role.
• Practical experience and global mastery in global quality standards and regulations governing medical products.
• Outstanding communication skills (both written and spoken), to all layers of the organization, including executive level.
• Emotional Intelligence/cultural awareness (interacting globally).
• Ability to think in a clear, decisive manner, remaining calm under stressful and challenging conditions.
• Ability to efficiently work through quality, organization and business issues with a focus on solutions and proactive contingency planning in support of the customer and business objectives.
• Ability to apply budgetary analysis principles and effective allocation of internal/external resources.
• Strong understanding of risk management principles and ability to apply these principles in day-to-day quality management activities, compliance issues, and business challenges.
• Commercially astute and customer focused.

Working Conditions:

• Fulltime position

Travel:

• Role is remote-based with preference to location in the United Kingdom
• Travel is expected to be approximately 25% with projected international travel

Language Skills Required:

• Speaking: English
• Writing/Reading:  English

Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen too.  It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.

This is stepping up to a challenge.

This is work that’ll move you.

#ForeverCaring #ForeverConvatec #WeAreConvatec

#LI-DB1

#LI-REMOTE

 

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com.

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Already a Convatec employee?

If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!

At HCSC, we consider our employees the cornerstone of our business and the foundation to our success. We enable employees to craft their career with curated development plans that set their learning path to a rewarding and fulfilling career.

Come join us and be part of a purpose driven company who is  invested in your future!

Job Summary

This position is responsible for monitoring and overseeing the corporation’s, its subsidiaries, and its subcontractors compliance with federal, state and local regulatory and contractual obligations applicable to NM Medicaid and chip programs. This position oversees administration of the compliance program, including identifying potential areas of non-compliance by conducting investigations and/or performing compliance reviews, performing risk assessments, consulting with the business owners to remediate identified issues of non-compliance and reporting compliance metrics, preparing reports and/or disclosures to the board of directors, it committees, compliance committees and governmental agencies, and providing advice and guidance to operational areas regarding proper policies and procedures.

Job Responsibilities

• Provide planning, implementation and monitoring of activities associated with regulatory and contractual requirements for government programs. Develop process and procedure flows to ensure that reports, or specific obligations mandated from government agencies are implemented by the appropriate business areas. Coordinate the development of policies and procedures designed to maintain the accuracy and timeliness of completing contractual requirements. Ensure that the process of filing certification and attestations with the government is documented.
• Analyze and oversee supportive data to prevent regulatory sanctions, foster regulatory relationships and integrate operations with regulatory requirements. This includes coordination with internal departments, i.e. Internal Audit, Special Investigations Department, Legal, as well as subcontractors to align for appropriate information collection and reporting. Work closely with Internal Audit and other business areas for the resolution of audit findings or other issues raised by the Government regarding non-compliance.
• Review and interpret regulatory documentation for adherence to standard criteria. Develop programs to accommodate corporate goals. Review filings made to government agencies.
• Perform reviews of various aspects of government programs and conduct investigations where necessary including investigations of any subcontractor, first tier entities, downstream entities and/or related entities.
• Prepare reports based on the completion of compliance reviews and investigations related to government programs.
• Design, implement, and monitor program projects and initiatives in all aspects of Government Programs.
• Serve as a resource on problematic issues generated from changing laws, regulations and guidance to maintain consistent/accurate interpretations.
• Participate in enterprise-wide initiatives and task forces in order to provide advice and guidance on compliance with government programs requirements.
• Manage reporting system to ensure that all contacts regarding possible non-compliance or misconduct involving a government program are properly logged, investigated and resolved including making recommendations to the Compliance Officer regarding whether disclosure should be made to the government, corrective actions, and disciplinary actions. Maintain documentation for each report of potential fraud, waste and abuse received through any reporting method (i.e. hotline, mail, in-person, exit questionnaires) which describes the initial report of non-compliance, the investigation, the results of the investigation, and all corrective actions and/or disciplinary action(s) taken as a result of the investigation.
• Direct research on laws and regulations to support investigative reviews related to government programs.
• Direct applicable audit functions to support investigative reviews of any potential wrongdoing related to government programs.
• Develop Corrective Action Plans and make recommendations regarding new policies and procedures based on risk assessments, compliance reviews, investigations or weaknesses.
• Identify needs and opportunities for communication to management regarding compliance issues and policies.
• Identify areas for training and communication to employees directly or indirectly related to Government Programs regarding compliance.
• Monitor Fraud, Waste and Abuse program as required under CMS guidelines and Medicaid contract including coordination with Special Investigations Department and Internal Audit
• Provide briefings on government programs requirements to the Compliance Officer, to the Board and its Committees and Compliance committees.
• Communicate and interact effectively and professionally with co-workers, management, customers, etc.
• Comply with HIPAA, Diversity Principles, Corporate Integrity, Compliance Program policies and other applicable corporate and departmental policies.
• Maintain complete confidentiality of company related business.
• Maintain effective communication with management regarding development within areas of assigned responsibilities and perform special projects as required or requested.

Required Job Qualifications:
* Bachelor’s Degree
* 8 years of auditing or investigative experience with a focus in government or compliance reviews.
* 5 years of managerial experience.
* Management and negotiation skills.
* Effective verbal and written communication skills.

Preferred Job Qualifications:
* 3-5 years of experience in a government programs health plan

*This is a hybrid role based in Albuquerque, NM and will sit in this office 3 days/week*

#LI-Hybrid

INJLF

#LI-EL1

Are you being referred to one of our roles? If so, ask your connection at HCSC about our Employee Referral process!

HCSC Employment Statement:

HCSC is committed to diversity in the workplace and to providing equal opportunity and affirmative action to employees and applicants. We are an Equal Opportunity Employment / Affirmative Action employer dedicated to workforce diversity and a drug-free and smoke-free workplace. Drug screening and background investigation are required, as allowed by law. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

As a Branch Head reporting to the Director of Finance, the officer’s responsibilities shall include:
• Lead a team to provide outstanding service delivery in Statutory Reporting, Financial Operations, Cash Management, Grants Administration, Tax and Procurement.
• Partner and guide internal stakeholders on internal financial processes to ensure compliance and seek continuous improvement based on feedback to enhance efficiency.
• Oversee the following areas:
• Statutory Reporting – audit liaison and timely issuance of group consolidated
financial statements.
• Financial Operations - payments, collections, payroll processing and staff claims.
• Cash Management – bank reconciliation, bank account management and other banking matters.
• Grants Administration – claims processing and submission of fund request to
funding agencies/ministries.
• Tax – filing of GST returns and working with tax consultants/IRAS on tax matters relating to overseas attachments.
• Procurement – provision of advisory and vetting services to procuring Departments to ensure that the activity is executed efficiently and in accordance with Procurement guidelines.
• Governance and risk management – identify risks and implement controls/action plan to close the gaps.
• Reporting and returns - timely and accurate reporting/submissions of returns to internal and external stakeholders, including to the Board.
• Ensure effective and efficient service delivery, in compliance with Government Instruction Manuals and standard operating procedures.
• Oversee and coordinate all audit activities related to Branch’s operations.
• Drive mindset of service excellence/transformation to achieve the corporate vision of a High-Performance Organisation.
• Mentor and motivate team members towards achieving professional growth and potential.

Requirements
• 8 to 10 years’ working experience in Financial Operations and Statutory Reporting.
• Candidates experienced in manging Government grants and Government Procurement will have an advantage.
• Experienced in leading a medium-sized team for at least 3 years.
• Educational background in Accountancy or Finance would be preferred.
• Candidates who possess relevant Accounting certifications (such as CA, CPA) will have an advantage.
• Strategic and critical thinking with a strong governance mindset.
• Excellent communication skills with the ability to design effective communication strategies and messages to influence and achieve desired organisational outcomes.
• Analytical and meticulous, with good monitoring and resource deployment/organization skills

Other Job Details:

• This is an individual contributor role

• This role reports into the Sr. Director

*Last date to apply is March 16, 2024*

The annual base salary for this position ranges from $149,200.00 to $248,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Quality Assurance and Control

Career Category

Operations

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

DIRECTOR, CLINICAL QUALITY THERAPEUTIC AREA LEAD

Live

What you will do

Job Description

Let’s do this! Let’s change the world! In this vital role you will report to the Associate Vice President, Clinical & Research Quality (CRQ) and be responsible for a team of 5-10 colleagues. The Director, Clinical Quality Therapeutic Area Lead provides proactive end to end quality oversight strategies for the development and implementation of a customized risk-based quality assurance strategy for the clinical development program.

Director, Clinical Quality Therapeutic Area Lead will manage end to end Quality Oversight within one of three Therapeutic Areas (TAs): Oncology/Biosimilars, Immunology & Rare Diseases, and General Medicine. The TA Lead is responsible for implementing a risk-based quality strategy that advances quality by design principles for the full clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals).

You will be a vital role who develops deep knowledge of the TA’s clinical trials and provides oversight and quality management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.

Responsibilities

• Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes
• Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights
• Provide oversight for the development and implementation of Quality Plans
• Establish Regional expertise to ensure quality and compliance to local regulations
• Support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods)
• Develop TA-specific Quality Assurance plans that are risk based and efficient. This includes TA specific audit plans, and the execution of audits (investigator site audits, affiliate audits, and study level audits)
• Support Clinical Trial Teams for all quality management activities, including Deviations/CAPAs, Inspection Readiness activities, and Inspection Management, and Serious Breaches/ Privacy Issues
• Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods using AI and Natural Language Processing, and other advanced data analytics methods)

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications:

Basic Qualifications:

Doctorate degree and 4 years of Quality Management, Quality Assurance, or other relevant experience

Or

Master’s degree and 8 years of Quality Management, Quality Assurance, or other relevant experience

Or

Bachelor’s degree and 10 years of Quality Management, Quality Assurance, or other relevant experience

In addition to meeting at least one of the above requirements, you must have a minimum of 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• 5 years of managerial experience directly leading people in a multi-tiered organization and an ability to build a high performing team.
• 5 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.
• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise. (including oversight of CAPAs, deviations, etc.)
• Thorough understanding and deep knowledge of Clinical Development activities / Clinical Trials and Global Regulations.
• Knowledge of the Regulatory Submission and Inspection Management procedures.
• Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions.
• Excellent verbal and written communication skills, including strong business writing abilities and active listening.
• Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format.
• Strong analytical, critical-thinking, and decision-making abilities.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

.

Salary Range

187,972.00 USD - 214,012.00 USD