Total 108 Manager level Quality Assurance / Control job vacancies in Naval Base Newport, Rhode Island

What a System Quality Program Manager does at HP:

Manage Quality Programs:

• Lead quality assurance programs from initiation through closure, ensuring alignment with project scope, goals, and deliverables.
• Oversee all aspects of quality program management, including planning, budget and resource control.
• Conduct System At Glance Test, Workflow Duration Test, and Continuous Regression Test.
• Support priority test projects with direction, maintaining relationships with internal stakeholders and sharing information with testers via standardized reports and regular stand-up meetings.

Collaborate with Cross-Functional Teams:

• Work closely with cross-functional teams to define program requirements, identify risks, and ensure successful project execution within defined timelines, resources and budgets.

Execute Quality Assurance Plans:

• Define and manage comprehensive test plans to ensure HP Print ecosystem integration quality.
• Oversee test coverage, schedules, and resource adjustments to meet program objectives.

Monitor and Analyse Quality Metrics:

• Track quality metrics to ensure compliance with HP’s standards, conduct data analysis to identify improvement areas, and drive continuous improvement initiatives.
• Lead Data-Driven Decision Making.

Facilitate Communication:

• Act as a primary quality contact for stakeholders, communicating program status, risks, and escalations effectively.
• Prepare and maintain QA-related documentation, including test plans, test matrices, and testing reports.
• Provide regular updates and insights to senior management.

Encourage a Culture of Innovation and Continuous Improvement:

• Promote a collaborative environment, integrating new technologies and quality methodologies, and driving process enhancements.

Individuals who do well in this role at HP, usually possess:

• Four-year Degree in Computer Science, Software Engineering, Information Systems, Information Technology, or any other related discipline or commensurate work experience or demonstrated competence.
• Typically has 0-1 years of work experience, preferably in software quality assurance, test harnesses and QA focused tools, or a related field.
• Good to have skills and knowledge: Agile Methodology, CI/CD, Computer Science, JIRA, Scrum (Software Development), Software Development, Software Engineering, Software Quality (SQA/SQC), Software Testing.
• Test Planning, Knowledge in Quality and defect management.
• Any certifications are a plus: Project Management Professional (PMP) Certification, Lean Six Sigma Certification or equivalent quality certifications, Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), Certified Software Quality Engineer, Certified Associate in Software Quality (CASQ), Certified Software Test Engineer (CSTE).

Sustainable impact is HP’s commitment to create positive, lasting change for the planet, its people, and our communities. This serves as a guiding principle for delivering on our corporate vision – to create technology that makes life better for everyone, everywhere.

HP is a Human Capital Partner – we commit to human capital development and adopting progressive workplace practices in Singapore.

• You will ensure the safety and operational capabilities of nuclear reactor plant systems having oversight on highly sophisticated quality control procedures and skills.
• You will utilize knowledge of receipt inspection procedures, techniques, requirements, and recording inspection performance or documentation of deficiencies.
• You will lead or mentor a group of inspectors with varying individual knowledge levels in safety and operations in a nuclear reactor plant onboard ships.

Job Description:

• Responsible for implementing all QA/QC inspection and testing, as required by specifications or by regulatory requirements and shall be familiar with all aspects of testing required for commercial building including the quality testing requirements of local Authorities such as the Standards, Productivity and Innovation Board (SPRING Singapore)
• Monitor progress and quality of all C&S, Archi, M&E and security system works, including CONQUAS, Green Mark etc to ensure compliance to project and statutory requirements
• Review procedures to improve productivity.
• Attends meetings with client, authorities, subcontractors and consultants.
• Ad-hoc duties as assigned

Requirements (Qualification & Experience):

• Preferably university graduate in Electrical/Security/Computer Engineering or IT recognised by PEB Singapore.
• Ten (10) years of relevant experience in the implementation and management of quality control systems
• Familiar with BIM for construction, Green Mark, CONQUAS and relevant authority requirements
• Full time stationed on site during construction

Responsibilities:

• Oversees project costing, budget allocation, expenditure monitoring and cost forecasting
• Reviews the project revenue update and project cash flow
• Oversees Change Order Management and Claims with clients, vendors and subcontractors
• Ensures timely commercial and cost reporting
• Reviews and evaluates vendors and subcontractors CBEs
• Coordinates with respective stakeholders for payment milestone requirements

Requirements:

• Bachelor’s Degree in any Engineering disciplines
• Minimum 5 years of relevant experience as project control manager
• Possess good communication and interpersonal skills

Our Addresses and Working Hours:

Seatrium (SG) Pte. Ltd.

Tuas Yard

51 Pioneer Sector 1, Singapore 628437

(Islandwide transport provided)

Mon - Thu: 8:00am – 5:15pm

Fri: 8:00am – 4:30pm

Interested candidates are invited to send us an updated resume with your current and expected salary and earliest availability.

We regret that only shortlisted candidates will be notified.

Please note that your personal data disclosed to Seatrium Limited and our group of companies, shall be used for the purposes of evaluation, and processing in accordance with our recruitment processes and policies. By providing your personal data, you have consented to the aforesaid purpose under the provisions of the Personal Data Protection Act 2012.

Job Description:

• Building & Demolition projects

• Restoration and Refurbishment Works

• Additions and Alteration Works

• Driving IDD implementation for the works

Job Requirements:

• Degree in Architecture, Civil & Structural Engineering, Mechanical & Electrical Engineering, Building Science or Quantity Surveying from a University recognized by the respective Professional Bodies or Professional Institutions.

• Minimum 5 years of practical experience in the design and/or construction management of construction projects with contract value of $5 million and above.

Job Description:

• Infrastructure works like roads, drains, sewer works and ancillary works;

• Rectification of infrastructure works such as roads, drains, sewers and ancillary works for handing over to authorities;

• Provision of amenities such as footpaths/pavements, Personal Mobility Device (PMD) tracks, cycling paths, sheltered linkways, decking, etc;

• Construction of surface parking for cars, buses, heavy vehicles;

• Road traffic and junction improvements such as installation of road signage, lane markings;

• Construction of bus stops, bus bays, pedestrian overhead bridges and associated works;

• Earthworks and disposal of debris, removal of stockpiles and other unusable material;

• Slope protection and rectification, Trial trench works;

• Minor land clearances and clearing of overgrown vegetation;

• Instrumentation & Monitoring

Job Requirements:

• Degree in Civil & Structural Engineering from a University recognized by the Professional Engineers Board (PEB) and/or accreditation recognized by the Professional Engineers Board.

• At least 5 years of practical experience in the management of building (e.g. new building, R&R and A&A projects) or infrastructure (e.g. road, drain, sewers, services diversion) projects with contract value of $5 million and above.

• The PM must be familiar with PSSCOC.

• At least 2 years of relevant working experience or involvement in Integrated Digital Delivery (IDD) for project delivery and built environment industry.

• Strong, mature and proven ability to organize, manage and motivate a project team.

Job Description:

• Infrastructure works like roads, drains, sewer works and ancillary works;

• Rectification of infrastructure works such as roads, drains, sewers and ancillary works for handing over to authorities;

• Provision of amenities such as footpaths/pavements, Personal Mobility Device (PMD) tracks, cycling paths, sheltered linkways, decking, etc;

• Construction of surface parking for cars, buses, heavy vehicles;

• Road traffic and junction improvements such as installation of road signage, lane markings;

• Construction of bus stops, bus bays, pedestrian overhead bridges and associated works;

• Earthworks and disposal of debris, removal of stockpiles and other unusable material;

• Slope protection and rectification, Trial trench works;

• Minor land clearances and clearing of overgrown vegetation;

• Instrumentation & Monitoring

Job Requirements:

• Degree in Civil & Structural Engineering from a University recognized by the Professional Engineers Board (PEB) and/or accreditation recognized by the Professional Engineers Board.

• At least 5 years of practical experience in the management of building (e.g. new building, R&R and A&A projects) or infrastructure (e.g. road, drain, sewers, services diversion) projects with contract value of $5 million and above.

• The PM must be familiar with PSSCOC.

• At least 2 years of relevant working experience or involvement in Integrated Digital Delivery (IDD) for project delivery and built environment industry.

• Strong, mature and proven ability to organize, manage and motivate a project team.

Job Description:

• Develop & implement Project Quality Plan, all QA/QC inspection and testing, as required by contract specifications and by regulatory requirements;
• Lead and manage the QA/QC team in the various disciplines including but not limited to qualified welding and fabrication inspection.
• Oversee preparation of Welding Procedure Specification, Welder Qualification Record and Quality Procedures;
• Ensure compliance to the overall Quality Management System, policies and standards
• Develop and implement preventive measure and corrective actions for non-conforming products include training to ensure awareness of quality procedures and specific responsibilities in the QA/QC process.
• Able to audit QA/QC activities of the staff and sub-contractors to assess conformance with the QA/QC procedures.
• Liaise and attend with consultants and subcontractors for QAQC activities
• Carry out inspections to in-progress / completed works and ensure Works are in accordance to project specification.
• Raise report of any non-conformances and carry out root cause analysis.
• Monitor corrective actions and process improvement.
• Manage subcontractors to clear defects
• Document QAQC records and prepare handover documents.

Requirements:

• Degree in Mechanical Engineering or equivalent
• Minimum 8 years of relevant experience in the setting up, day to day management, testing and inspecting, auditing and reporting of all aspects of the QA/QC of similar major projects in the waste, oil and gas, water or petrochem industries.
• Good Organizational and planning skill.

The incumbent is responsible for managing the company's freight operations, ensuring that goods are transported efficiently, cost-effectively, and in compliance with regulatory requirements. This role involves coordinating with carriers, negotiating contracts, and overseeing the logistics team to streamline freight processes and improve overall supply chain performance.

JOB RESPONSIBILITIES:

1. Operational Management:

• Plan, organize, and oversee the daily operations of freight management.
• Monitor and manage the performance of carriers and freight service providers.
• Through the used on AI and pre-alert tool, proactively response to shipments to prevent disruption

2. Compliance and Documentation:

• Ensure compliance with national and international shipping regulations and standards.
• Prepare and review shipping documents, including bills of lading, customs documentation, and other required paperwork.
• Handle any legal or regulatory issues related to freight transportation.

3. Customer Service:

• Address and resolve freight-related issues and inquiries from customers, ensuring high levels of satisfaction.
• Work with other departments to manage delivery exceptions and provide timely updates to customers.

4. Reporting and Analysis:

• Prepare regular reports on freight performance, including cost analysis, delivery metrics, and other key performance indicators (KPIs).
• Analyze data to identify trends, areas for improvement, and potential risks.
• Make recommendations for process improvements based on analysis.

5. Technology and Systems:

• Utilize freight management software and other technologies to streamline operations and improve efficiency.
• Stay updated on industry trends and advancements in technology.

JOB REQUIREMENTS

1. Bachelor's degree or equivalent in logistics, supply chain management, business administration, international trade or a related field.
2. Minimum of 5 years of experience in freight operations or logistics management.
3. Experience in trade compliance, customs knowledge in the region
4. Strong experience in trade compliance and customs knowledge, with an in-depth understanding of international trade laws and regulations.
5. Proven ability to conduct risk assessments and implement effective mitigation strategies.
6. Excellent analytical skills to interpret complex regulations and situations.
7. Knowledge of regional freight processes and documentation.
8. Strong analytical skills to interpret complex regulations situation
9. Willingness and ability to travel on short notice as required.

Responsibilities:

• Manage the implementation of Reckitt Quality Systems to support business strategies by ensure compliance to Reckitt Quality Manual and applicable local regulatory requirements.
• Assess, communicate, and implement policies, procedures and initiatives from Global / Regional Quality.
• Increase Quality mindset of the site organization by leading Quality awareness enhancement programs, such as Quality Month Awareness etc.
• Monitor and share site functions’ Key Quality performance indicators and identify continuous improvement opportunities that lead to a higher performing quality culture.
• Lead site Change Control Management to comply with Global Quality System requirement and verify the effectiveness of approved change requests. Liaise with Global / Regional Change Control community as required.
• Manage document control system for use by functions within the Singapore Supply Centre site. Review and approve local SOP in the PDMS (Procedural Documentation Management System) to ensure they met Reckitt quality system requirements, and have incorporated relevant new learning / processes and regulatory changes.
• Ensure timely review of materials and products quality and perform disposition to meet production schedule and delivery deadlines.
• Coordinate and facilitate non-conformance (NC) investigations, and ensure that root-cause analysis by the investigation team is thorough and complete, and appropriate corrective and preventive actions (CAPA) are put in place to minimize product loss.
• Prepare Potential Early Quality Alert (EQA) when required, and follow-up on sharing of key learning.
• Support food safety /HACCP team for HACCP 2.0 & other food safety requirement eg. Contaminant, Food fraud etc.
• Implement an effective internal audit program and ensure compliance to requirements of: GMP / HACCP pre-requisite programs, Quality systems, Halal assurance system.
• Lead site team to prepare for audits (e.g. Global/Regional Quality Audit, External Certification Bodies), and ensure agreed audit findings are corrected and preventive measures are put in place.
• Organize Annual Product Review to drive product quality improvement.
• Support innovation projects and timely launch of new production introduction.
• Manage the customer complaint handling system – evaluation, investigation and corrective/preventive action planning, implementation and monitoring.
• Manage the local Mock Recall exercise as per Reckitt procedures.
• Assist Senior Manager, Quality in liaison with Global / Regional Quality in crisis situations, such as a potential product recall, or high-profile customer complaint.
• Represent the Singapore Supply Centre in various quality professional communities (e.g. GMC) to create a network for teaching and learning and identification of best practices.
• Support OE/Engineering improvement projects to ensure compliance to Reckitt quality systems requirements.
• Support Procurement team to help existing material suppliers to meet Reckitt Quality standards through sharing / training. Support the RMAQ (Raw material attribute questionnaire) review process for new material suppliers.
• Develop succession and development plans for direct reports, ensuring for their career growth and succession.
• Perform other tasks, roles or projects that may be assigned by the Plant Director or Senior Manager, Quality from time to time.

Requirements:

• Bachelor degree in a scientific or technical discipline (Chemistry, Microbiology, Food Science or related)
• 5 years of Quality Assurance / Quality Systems in a regulated food manufacturing industry. Experience in manufacturing of infant/follow up formula will be of advantage.
• Performed supervisory role for min 3 years.
• Experienced in establishing/implementing Quality Management Systems, Food Safety Management System, Halal Assurance System.
• Preferably with extensive quality system audit experience.
• Experienced in collaborating with various functional roles within the organization to develop strategies and execute action plans to resolve critical issues.
• Strong understanding and working level knowledge of quality systems including HACCP, change control, corrective action/preventive action, process/product qualification, and the successful application of these strategies across an organization to produced desired results.

The incumbent is responsible for managing the company's freight operations, ensuring that goods are transported efficiently, cost-effectively, and in compliance with regulatory requirements. This role involves coordinating with carriers, negotiating contracts, and overseeing the logistics team to streamline freight processes and improve overall supply chain performance.

JOB RESPONSIBILITIES:

1. Operational Management:

• Plan, organize, and oversee the daily operations of freight management.
• Monitor and manage the performance of carriers and freight service providers.
• Through the used on AI and pre-alert tool, proactively response to shipments to prevent disruption

2. Compliance and Documentation:

• Ensure compliance with national and international shipping regulations and standards.
• Prepare and review shipping documents, including bills of lading, customs documentation, and other required paperwork.
• Handle any legal or regulatory issues related to freight transportation.

3. Customer Service:

• Address and resolve freight-related issues and inquiries from customers, ensuring high levels of satisfaction.
• Work with other departments to manage delivery exceptions and provide timely updates to customers.

4. Reporting and Analysis:

• Prepare regular reports on freight performance, including cost analysis, delivery metrics, and other key performance indicators (KPIs).
• Analyze data to identify trends, areas for improvement, and potential risks.
• Make recommendations for process improvements based on analysis.

5. Technology and Systems:

• Utilize freight management software and other technologies to streamline operations and improve efficiency.
• Stay updated on industry trends and advancements in technology.

JOB REQUIREMENTS

1. Bachelor's degree or equivalent in logistics, supply chain management, business administration, international trade or a related field.
2. Minimum of 5 years of experience in freight operations or logistics management.
3. Experience in trade compliance, customs knowledge in the region
4. Strong experience in trade compliance and customs knowledge, with an in-depth understanding of international trade laws and regulations.
5. Proven ability to conduct risk assessments and implement effective mitigation strategies.
6. Excellent analytical skills to interpret complex regulations and situations.
7. Knowledge of regional freight processes and documentation.
8. Strong analytical skills to interpret complex regulations situation
9. Willingness and ability to travel on short notice as required.

Job Description:

• Drive PGCS Quality programs and policies compliance across site, by partnership with functional stakeholders.
• Key contributor/promoter to the advancement of Quality function across the sites; creating and driving critical/key business objectives in line with supporting/partnering with Operations, Supply Chain functions etc.
• Lead incident management and resolution and champion customer quality across Singapore. Site lead for Quality and Food safety crisis mgmt.
• Lead the implementation of the Singapore Quality Strategy including communication, project management and roll out activities.
• Lead continuous improvement culture/productivity initiatives to support site BPI process, demonstrating best practices to implement all quality improvements
• Drive, support and champion KPIs, key Quality metrics, etc.
• Act as a business partner to other functions whilst championing Quality, to ensure an extended and consistent quality focus.
• Be a key member of the Site Leadership team and value add in driving functional and site agenda.
• Support and provide strategic guidance around NPIs, validation, Total Quality System, Compliance, Capital investment, etc.
• Partnership with other functions ensuring change control risk assessment and validation in place for Network capacity projects and other key projects and significant changes.
• Financial Management; Budgetary and AOP responsibilities/input.
• Compliance; drive partnership with other functions through the Quality team to achieve key business goals for the control environment. Compliance with all regulations and 3rd party auditing requirements.
• Provide strategic quality leadership to the extended Quality Team
• Organisation design & sustainability of a highly effective team with appropriate succession plan. Encourage, manage & promote people-related activities/processes, partnering with HR
• Develop capability, personal growth and career development for direct reports, support these activities with DRs’ associated teams.
• Play in instrumental role in developing the overall team capability, supporting and aligning with overall plant culture.
• Ensure the smooth transition of new products to the Singapore facilities.
• Manage the complexity of additional materials, packaging and concentrate components from a quality perspective as portfolio expands
• Support and implement PGCSSC global quality initiatives
• Systems improvements (including IT systems) in terms of Processing, GMP, Product Safety, Disposition and Traceability.
• A requirement of the role is that you must adhere to all PepsiCo Health & Safety requirements.

Qualifications :

• Bachelor’s Degree in Science, Food Technology, Chemistry or any other related discipline
• Minimum 7 years of relevant experience as a supervisor in operating Laboratory environment, manufacturing concern/MNC
• Ability to manage senior stakeholders and leadership team members
• Experience in People Management and prior supervisory skill
• Possess knowledge of and experience in GLP, HPLC / GC operation, SAP QM module and LIMS management
• Strong leadership presence, ability to manage and co-ordinate with cross-functional teams on investigation analysis, troubleshooting and issues resolution
• Knowledge of food safety quality standards such as HACCP and FSSC 22000
• Ability to lead change and drive behaviours
• Ability to organize and manage multiple priorities in high-pressure work environment
• Strong collaboration and influencing skills
• Excellent communication and interpersonal skills, both verbal and written with ability to clearly articulate ideas and proposals to all levels of the organization
• Positive and Can-do Attitude
• Willing to stretch and take additional responsibilities when needed
• Lead by example to others

Kindly note that this is a short-term role based in Singapore.

Cyber Compliance and Regulatory Affairs ManagerPermanent - £75k to £95k + potential bonus and benefitsLocation: Hybrid/remote - Newport

Your new company

A leading utilities organisation in Wales are currently looking for a Cyber Compliance and Regulatory Affairs Manager to come in and spearhead the organisations compliance and regulatory affairs estate.

Your new role

You will be responsible for managing the Cyber Compliance and Regulatory Affairs. With this role, you will be interfacing with the Government and OFGEM on a regular basis, so you will need to have strong experience dealing with entities of that ilk, as well as be an expert in all things cyber compliance and regulatory related.

• Articulate and understand the strategic and future outlook and requirements from competent authorities in the field of cyber and physical security. Maintain compliance with legislation, sector-specific regulations and industry standards.
• Prepare, develop and present back all relevant business cases, financial analysis, cyber resilience investment documents, CAF aligned workstreams, and all associated documentation for both ad-hoc liaison with regulatory bodies and formal submissions.
• Develop, document and 'own' the production of the clients' NIS Annual Report, and its Annual PCD Reporting Pack.
• Assist the Head of Cyber Resilience in ensuring that the organisation complies with the NIS Regulations and the associated CAF profile requirements.
• Input in the development and continuous refinement of the Cyber Security Strategy

What you'll need to succeed

You will need to be able to influence and collaborate with other teams in the organisation, and have the ability to build strong internal relationships with other members in the business as well as other third parties and government bodies.

• A strong understanding of the NCSC's Cyber Assessment framework (CAF) and the ability to understand the de-facto controls required to meet Indicators of Good Practice.
• A solid understanding of cyber security standards and control frameworks including ISO27001, NIST, CIS etc., and the current and evolving regulatory landscape in the context of NIS and wider cybersecurity legislation.
• Experience of representing and being 'the face' of an organisation to a Regulator and building strong collaborative relationships.
• Excellent communication and leadership/management skills.
• Strong understanding of legal and regulatory requirements related to cyber security in a UK Operator of Essential Services (OES) of Critical National Infrastructure.
• Experience with DESNZ would be advantageous, but not essential.

What you'll get in return

This role is available for hybrid or remote working, although the contract won't state fully remote, I have been assured that the cyber team are able to work remotely, other than the occasional on-site meeting or catch up.

• 25 days holiday plus bank holidays
• Annual bonus based on personal and company performance
• Your 5% pension contribution will be doubled by the company, meaning 15% of your annual salary will be put into the pension pot (with you only contributing 5%).
• And more!

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.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.

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Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

This is an exciting position who is responsible for QA oversight of Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies for the Cell and Gene Therapy entity. Role will provide oversight and sterility assurance expertise to Operations to assure aseptic processing meets US and international aseptic processing requirements ( FDA Sterile Product Aseptic Processing Guidance and Eudralex, Annex 1,” Sterile Medicinal Drug Products”, ISO 13408 and 21CFR820).

The role will also provide strategic plan and expertise for the development and implementation of the Microbial Control Strategy. Develop, document and manage microbial control strategy for production processes from incoming raw materials through final product release.

Key responsibilities:

• Provide support and expertise to ensure that Cell and Gene Therapy (CGT) and Media preparation operations and support functions for Cleanroom management, Materials Management, Aseptic practices, Environmental monitoring (EM). Sterilisation methods, and Aseptic process simulations (APS) to confidently deliver CT products to patients with the highest quality sterility assurance level.
• Review policies and procedures and related completed media fill/APS documentation, Environmental Monitoring sample plans, cleanroom qualifications, environmental monitoring excursions, deviations and sterility failures.
• Provide Sterility assurance expertise to support APS/EM deviations and investigations, CAPAs and Complaints related to aseptic processing.
• Review of sterile filter validations, integrity testing and procedures.
• Provide expert support and assessment to business partners including production, MSAT, Engineering, QC and QA assuring adequate facilities contamination prevention practices, monitoring tools are provided to production to guarantee the best EM indicator levels.
• Involvement in global harmonization/ efficiency projects; begin to lead aspects of global projects within specific areas.
• Represent site in global forums from sterility assurance perspective. Collaborate with stakeholders of different functions to lead/implement various global/site projects to support sterility assurance.
• Support regulatory and client audits as Aseptic sterility assurance subject matter expert
• Responsible for the generation of key performance indicators, GEMBA walks, regulatory compliance and efficiency targets.
• Communicate quality operations and compliance perspective effectively to senior management.
• Understand and articulate company business strategy. Maintains a broad view of the business recognizes changes and trends in the appropriate area in which the individual operates.

Key requirements:

• Engineering/ Life Science Diploma/Degree or higher from recognized institution with significant years of QA or QC Sterile processing and Microbial experience in similar capacity.
• GMP experience in the biologics industry is required.
• Working knowledge of microbiological and sterility testing, media fills, environmental monitoring , clean room qualification and management, quality control endotoxin testing and microbiological control strategy required.
• Experience with oversight of aseptic processing and the associated international aseptic processing regulations are required.
• Experience in cell culture, cell or gene therapy experience is a plus.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

R63423

Job Overview:

The QA Manager will be responsible for managing and overseeing all quality assurance activities within the organization, ensuring that products and services meet all quality standards. The ideal candidate will have in-depth knowledge of Quality Management Systems (QMS) and ISO certification processes, driving continuous improvement and compliance across the organization. This role plays a critical part in ensuring the company meets regulatory and customer expectations.

Key Responsibilities:

• Quality Management System (QMS):Develop, implement, and maintain the Quality Management System (QMS) in alignment with ISO standards (e.g., ISO 9001, ISO 14001, etc.).
  Regularly audit and review QMS processes to ensure continuous improvement and compliance.
  Ensure documentation, procedures, and processes align with QMS requirements.
  
• ISO Certification Management:Lead and manage the ISO certification process, including initial certification, recertification, and internal audits.
  Coordinate with external certification bodies and manage relationships to ensure the company's certification status is maintained.
  Provide guidance and training to staff regarding ISO requirements and their roles in maintaining certification.
  
• Quality Assurance Oversight:Oversee all quality assurance operations, including quality control procedures, testing protocols, and defect management.
  Implement and enforce QA standards and policies throughout the production and service delivery processes.
  Collaborate with cross-functional teams (production, engineering, procurement, etc.) to ensure product quality.
  
• Internal Audits & Continuous Improvement:Plan and conduct internal quality audits, identifying non-conformance and areas for improvement.
  Lead root cause analysis for quality-related issues and implement corrective and preventive actions (CAPA).
  Promote a culture of continuous improvement by developing and executing process optimization initiatives.
  
• Compliance & Risk Management:Ensure company compliance with applicable regulatory requirements, industry standards, and customer expectations.
  Identify and mitigate risks associated with product quality and process inefficiencies.
  Maintain an up-to-date understanding of changes in quality regulations and standards relevant to the industry.
  
• Team Leadership & Development:Manage and mentor the QA team, fostering a culture of accountability, professional development, and continuous improvement.
  Provide leadership in solving complex quality issues, both internally and with external stakeholders.
  
• Customer & Supplier Interface:Act as the primary point of contact for quality-related concerns from customers and suppliers.
  Ensure effective communication of quality standards and expectations to suppliers and collaborate to resolve quality issues.
  

Qualifications and Skills:

• Education:Bachelor’s degree in Engineering, Quality Management, or a related field.
  Advanced degrees or certifications in Quality Assurance or Management (preferred).
  
• Experience:Minimum of 8-10 years of experience in quality assurance, with at least 3-5 years in a management role.
  Proven experience in managing QMS and ISO certification processes in manufacturing, engineering, or production environments.
  
• Technical Skills:In-depth knowledge of ISO standards, especially ISO 9001 (Quality Management), ISO 14001 (Environmental Management), or related certifications.
  Proficiency in quality assurance methodologies such as Six Sigma, Lean, FMEA, and root cause analysis.
  Strong experience in conducting audits and leading CAPA processes.
  
• Soft Skills:Excellent leadership, communication, and team management abilities.
  Analytical mindset with problem-solving skills and attention to detail.
  Ability to work cross-functionally and manage multiple projects simultaneously.