My client is seeking a QA Director / Associate Director to support the manufacture of Drug Substance and Drug Products at Contract Manufacturing Organizations (CMOs) to ensure that the drugs are in compliance with Good Manufacturing Practices (GMP) and are of the appropriate quality for their intended use. The position involves quality oversight of CMOs and liaison of quality related issues with Chemistry, Manufacturing and Control (CMC) Team and functional management. The scope of the position encompasses oversight of all aspects of drug manufacture through clinical development and into commercial phase.
The successful incumbent will be the QA Representative on CMC Teams responsible for drug manufacture. The position will require regular interaction with QA management at both the CMOs and company on matters concerning the product quality and CMO GMP compliance. This may include, but is not limited to:
Working with new CMOs to certify them as ready to begin manufacture of company’s products intended for administration to humans. This includes review and approval of contractor documentation necessary for the manufacture and testing, as well as approval of technology transfer protocols, discrepancies, deviations and reports.
- Responsible for QA oversight of China CMO’s and suppliers
- Interact with China CMO senior leaders to assure that QA / GMP interests are met and that relationships are properly maintained
- Establishing Quality Agreements with CMO’s
- Master Batch Record (MBR) review and approval as compliant with good manufacturing practice regulations, regulatory filings and quality agreements.
- Review of executed batch records, Certificates of Analysis and other documents to enable drug substance and final drug product release certifying batches as GMP compliant.
- Reviewing and communicating deviations at CMOs to CMC Teams and functional management. Obtaining and communicating deviation investigation requirements to CMOs and working with CMOs to investigate deviations until resolved.
- Review equipment qualification protocols and reports.
- Communication of changes between the company and CMOs. Monitoring documentation and implementation of changes until completed successfully.
- Performance of contractor quality system reviews and gap analysis as part of CMO selection and maintenance.
- Conduct GMP compliance audits of contractors and suppliers.
- Review CMC sections of regulatory filings.
- Provide support in the preparation for and during governmental regulatory agency inspections of company and company’s contractors.
- Developing, refining, and managing internal Quality Systems.