Job: Title: Associate Director of Quality Assurance (GCP)
Salary: Competitive
Location: York (Hybrid role)
SRG are supporting a global clinical lab services company in their search for an Associate Director of Quality Assurance.
The successful Quality Assurance Lead will be responsible for implementing strategies to allow successful delivery of high-quality Clinical Trials studies; by driving effective, efficient, global processes across the various aspects of our Quality and Operations.
Responsibilities:
- Work closely with the global QA leadership team to provide regional oversight of the quality assurance team.
- Promote and uphold a high performing culture through effective talent planning, selection, onboarding and continuing education. Curate and deliver comprehensive training plans and materials to foster successful onboarding and employee performance.
- Identify and implement strategies to maintain a culture of quality. Develop and execute holistic audit program, including internal audits, vendor audits, client audits and regulatory inspections, to ensure compliance.
- Leverage industry knowledge to refine our strategies and processes for delivering high quality clinical trials. Maintain working knowledge of industry and regulatory standards and requirements.
- Provide guidance and leadership as it relates to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), MHRA, FDA, data privacy and other regulatory standards as needed or directed. Serve as a responsive escalation point for Clinical Trials quality issues and concerns.
- Oversee and manage vendor management program to ensure supply compliance, computer systems validation program, and data privacy program regionally to ensure compliance.
Requirements:
- Bachelor's Degree required; Master's Degree preferred
- Extensive industrial experience in Quality Assurance, Regulatory Affairs, Laboratory Operations or a related field required.
- Experience of progressive leadership in QA required.
- Experience managing quality/regulatory department of regional responsibility.
- Experience with data privacy regulations preferred.
- Experience with Medicines & Healthcare products Regulatory Agency (MHRA), Food & Drug Administration (FDA); knowledge of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) strongly preferred.
If you are interested in finding out more, please apply using the provided link or send a copy of your CV directly to Alex Sheridan on or contact Alex directly on 0203 854 5418 for a confidential conversation.
SRG are the UK number 1 recruitment company specialising in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable, biotech, chemicals and medical devices sectors.
As scientists ourselves, our specialist sector knowledge and our passion are second to none. It's this combination that makes us different. We're committed to providing outstanding temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.
If you have a scientific background and this position is not relevant / suitable for you please feel free to get in touch or visit www.srg.co.uk to view our other vacancies.
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
