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Senior QA Manager GCP
3 months ago
Position title: Senior QA Manager GCP
Location: London
Company type: 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.
Key Responsibilities:
- Lead and execute GCP audits, including internal, external, and Investigator Site audits, in accordance with regulatory requirements and company SOPs.
- Develop and implement audit plans, schedules, and protocols to ensure thorough and efficient auditing processes.
- Collaborate with cross-functional teams to identify areas for process improvement and implement corrective and preventive actions (CAPA) as needed.
- Manage the Quality Management System (QMS), including document control, training, and compliance tracking.
- Oversee the Deviations and Change Control processes, ensuring timely investigation and resolution of quality issues.
- Provide expert guidance on GCP regulations, industry standards, and best practices to internal teams.
- 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.
Qualifications:
- Bachelor's degree in a relevant scientific discipline; advanced degree preferred.
- Minimum of 5 years of experience in Quality Assurance for pharmaceutical or biotechnology products.
- Extensive experience in GCP auditing, including internal, external, and Investigator Site audits.
- Strong knowledge of regulatory requirements and guidelines related to GCP and clinical trials.
- Proven expertise in QMS Management, Deviations, CAPA, and Change Control processes.
- Excellent communication skills, both written and verbal, with the ability to effectively interact with cross-functional teams and external partners.
- Detail-oriented with exceptional analytical and problem-solving abilities.
If this sounds like you then please apply now with an up to date CV
