Senior Quality Assurance Manager

1 week ago

London, Greater London, United Kingdom Clinical Professionals Limited Full time

Job Title: Senior Quality Assurance Manager - Global GCP Compliance

Company Overview:

Clinical Professionals Limited is a leading provider of clinical research and development services. We are currently seeking an experienced Senior Quality Assurance Manager to join our team.

About the Role:

We are looking for a highly skilled and motivated individual to lead our global GCP compliance efforts. The successful candidate will be responsible for ensuring that our clinical studies meet the highest standards of quality and regulatory compliance.

Key Responsibilities:

  1. Inspection Readiness: Supervise and manage activities to ensure inspection readiness, leading inspections from regulatory authorities such as FDA, EMA, CFDI, MFDS, PMDA, TGA, etc.
  2. Cross-Functional Collaboration: Collaborate across cross-functional teams to ensure unified approaches to inspection readiness strategies.
  3. Inspection Management: Assign inspection requests to appropriate subject matter experts (SMEs), provide guidance to ensure timely fulfillment, and write and update SOPs and tools for inspection readiness and management.
  4. QA Systems: Implement and maintain QA systems, such as investigations, deviations, CAPAs, and significant quality events (SQEs).
  5. Pre-Inspection Visits: Support and manage pre-inspection visits at investigative sites.
  6. Post-Inspection Activities: Fulfill all inspection commitments, respond to inspections, and conduct post-inspection activities, CAPAs, and resolve issues for timely closure.
  7. Global Inspection Status: Manage a central repository of global inspection status and updates.

Requirements and Qualifications:

  1. Experience: At least 7-10 years of experience in GCP-related QA functions in the pharmaceutical, biotechnology, or related healthcare industries.
  2. International GCP Requirements: Extensive understanding of international GCP requirements and standards in the pharmaceutical, medical device, and biotech industries.
  3. Leadership Skills: Proven ability to set strategies and drive initiatives for improving quality processes.
  4. Demonstrated Leadership: Demonstrated leadership skills and ability to mentor others.

Compensation: This position offers a competitive salary of £80,000 - £100,000 per annum, depending on experience. In addition, we offer a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.

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