Principal Quality Officer
PRINCIPAL QA ADVISOR | CAMBRIDGE (hybrid working) | Competitive Salary
Blackfield Associates are currently supporting a global CRO to recruit for a Senior / Principal QA Advisor to join the organisation on a permanent basis at their Cambridge site.
Flexibility with hybrid working is available.
As Senior/Principal QA Advisor you will be responsible to manage and execute a global supplier qualification program.
Key Responsibilities:
- Plan, coordinate, and manage the global supplier qualification program.
- Maintain and update the Global Supplier Database.
- Assess new suppliers based on risk-based criteria.
- Conduct periodic supplier assessments as per the established schedule.
- Monitor and report on supplier sustainability metrics.
- Lead meetings with high-risk suppliers and report on complaints or supplier issues.
- Participate in external audits related to supplier qualification and implement feedback for process improvements.
- Build and maintain strong relationships with suppliers, acting as the primary contact for external communications.
- Work with clients and internal teams to prepare and execute quality agreements.
- Maintain regulatory agency registrations (FDA, EMA, etc.) as required.
- Conduct study, process, and facility audits as needed.
- Stay updated on current regulations and guidance.
- Investigate and resolve supplier CAPAs (Corrective and Preventive Actions).
- Collaborate with QA and Operational teams to drive efficiencies across the group.
- Serve as the main contact for client quality agreements and regulatory registrations, ensuring accurate and current documentation.
Skills, Education & Qualifications:
- Strong understanding and experience in GxP or ISO regulated environments.
- Demonstrable auditing skills, with experience in establishing audit scope and developing relevant audit schedules and checklists.
- Knowledge of Quality Management Systems (QMS) and experience supporting systems like Deviations, OOS, Change Control, and CAPA.
- Excellent communication skills with the ability to interact effectively with customers, suppliers, and regulators.
- Preferably experienced within the pharmaceutical industry.
- Minimum qualification: BSc in a scientific field, recognized auditor certification, or equivalent industry experience.
STR Limited is acting as an Employment Agency in relation to this vacancy.
- Location: Cambridge, England
- Type: Permanent
- Industry: Science
- Recruiter: STR Group Limited
- Contact: Melissa Wylie
- Tel: +44 (0)2392 322 306
- Email: to view click here
- Posted: 2024-09-04 16:00:01 -
- View all Jobs from STR Group Limited
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