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.