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QA Manager/senior Manager
2 weeks ago
Biotech
Reports to:
Head of Quality
An exciting opportunity has come up with a well funded, clinical stage, Biotech partner of ours.
They are looking to add to the QA team with a Senior QA Manager GCP, who will have a proven track record in clinical QA.
This role will have a main focus on GCP Compliance, with the ideal candidate also being able to support overall QA development to help embed solid Quality foundations across the organisation.
You will play a critical role in ensuring compliance with industry regulations and maintaining the highest quality standards as the company enters a busy period of growth, assisting the Head of QA across the board.
Lead and execute GCP audits, including internal, external, and Investigator Site audits, in accordance with regulatory requirements and company SOPs.
Oversee the Deviations and Change Control processes, ensuring timely investigation and resolution of quality issues.
Stay current with industry trends, regulatory changes, and emerging best practices in GCP auditing and quality assurance.
Prepare and present audit reports, findings, and recommendations to senior management and regulatory authorities as needed.
Bachelor's degree in a relevant scientific discipline; Minimum of 5 years of experience in Quality Assurance for pharmaceutical or biotechnology products.
Strong knowledge of regulatory requirements and guidelines related to GCP and clinical trials.Proven expertise in QMS Management, Deviations, CAPA, and Change Control processes.
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