Senior Clinical Quality Assurance Lead
12 hours ago
Estimated Salary: £80,000 - £110,000 per annum
Clinical Professionals Limited has partnered with a global pharmaceutical organisation to source for an Associate Director, EMEA Clinical Quality Assurance (CQA). The successful candidate will lead as the GCP Subject Matter Expert (SME) on the development team, ensuring regulatory and quality compliance with GCP standards and other relevant regulatory requirements.
Key Responsibilities:- Act as GCP and EMEA regulation SME
- Contribute to and support a risk-based, scientifically-driven quality system for supporting GCP compliance
- 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
- Bachelor's degree in Biology, Chemistry, or related life sciences field
- Minimum 7-10 years of experience in clinical quality assurance or a related field
- 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%)
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