Quality Assurance Director for Pharmaceutical Organisation
1 week ago
Clinical Professionals Limited is seeking an experienced Associate Director to lead the Clinical Quality Assurance (CQA) team in EMEA.
Job Summary:
The ideal candidate will have a strong background in GCP compliance and regulatory inspections, with experience in managing quality documentation and collaborating with cross-functional teams. As the GCP Subject Matter Expert (SME), you will ensure adherence to ICH E6 guidelines and mentor staff to enhance quality and auditing skills.
About the Role:
- Act as GCP and EMEA regulation SME, contributing to a risk-based, scientifically-driven quality system.
- Lead the assessment and approval of vendors for potential use, offering guidance and oversight to ensure alignment with company quality and compliance standards.
- Collaborate cross-functionally to address and mitigate GCP quality and compliance issues.
- Ensure adherence to the ICH E6 Guideline for Good Clinical Practice and mentor staff to enhance quality and auditing skills.
- Manage quality documentation in Veeva QMS and Vault.
- Represent the company in regulatory inspections.
Requirements:
We are looking for a highly skilled professional with:
A Bachelor's degree in Biology, Chemistry, or related life sciences with at least 7-10 years of experience, or an advanced degree (MS, PhD, MBA) preferred with additional equivalent experience.Experience with managing regulatory inspections, collaborating with regulators and internal staff for inspection preparation.Experience with SOP development relevant to clinical, regulatory and medical processes.Proficient in GCP and EU clinical regulations, and risk-based quality systems aligned with ICH E6.Extensive knowledge of Phases I-IV (especially Phase III), with preference for regulatory approval, NDAs, and MAAs experience.Able to travel domestically and internationally (25-30%).Salary: €90,000 - €110,000 per annum, depending on experience, plus benefits.
Location: Central London / West End
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