Quality Assurance Manager, BIO/GLP
Exton, PA (Corporate)
Duties and Responsibilities:
- Implement, maintain and enhance quality procedures and systems to ensure compliance with US FDA, OECD, and ICH regulatory requirements including 21 CFR Part 58, 21 CFR Part 11, 21 CFR Part 320, and other relevant guidances and publications.
- Assist the Sr. Director with client audits / regulatory inspections and as back-up in their absence
- Assist with client RFIs and requests
- Assist the Sr. Director with audit schedules
- Conduct QA audits of bioanalytical laboratories and functions including but not limited to: ongoing process, data review audits, technical report, and study independent facility / process.
- Provide input to method, equipment, computer validation programs.
- Maintain GLP Master Schedule.
- Maintain appropriately detailed notes, audit reports, and records
- Provide input to documentation and data storage systems.
- Ensure that requirements and documentation for all GLP systems are kept current according to ever-changing guidelines and industry standards.
- Provide GLP training to staff as necessary.
- Effectively report quality issues to supervisor, Study Director, and Frontage management, as appropriate.
- Provide oversight and input to analytical and process investigations, CAPA and calibration programs, specifications, and supplier selection processes.
- Conduct outside vendor audits as may be required, including contract laboratories and raw material suppliers; resolve and follow-through on any quality issues.
- Review and maintain up-to-date Standard Operating Procedures (SOP).
- BS in Chemistry, or other related discipline
- Five (5) years of relevant experience in the pharma industry