Senior Clinical Quality Assurance Manager
1 week ago
Cpl Life Sciences is partnering with a global pharmaceutical organization to find a Senior Clinical Quality Assurance Manager for their EMEA team. This role involves leading the GCP Subject Matter Expert (SME) on the development team, ensuring regulatory and quality compliance with GCP standards and other relevant regulations.
Key Responsibilities:- Act as GCP and EMEA regulation SME to provide expert guidance and support
- Contribute to and support a risk-based, scientifically-driven quality system for supporting GCP compliance
- Lead vendor assessments and approvals, providing guidance and oversight to ensure alignment with company quality and compliance standards
- Cross-functional collaboration 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
- BS in Biology, Chemistry, or related life sciences degree with at least 7-10 years of experience, or advanced degree preferred with additional equivalent experience
- Experience managing regulatory inspections, collaborating with regulators and internal staff for inspection preparation
- Experience developing SOPs 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, with preference for regulatory approval, NDAs, and MAAs experience
- Able to travel domestically and internationally (25-30%)
The estimated annual salary for this position is around $120,000-$150,000, depending on qualifications and location. Cpl Life Sciences offers a competitive benefits package, including health insurance, retirement savings plan, and paid time off.
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