Associate Director/Director, Quality Assurance (12-117) FibroGen
FibroGen seeks a QA Director / Associate Director to support the manufacture of Drug Substance and Drug Products at Contract Manufacturing Organizations (CMOs) to ensure that FibroGen?s 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 FibroGen?s 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 CMO and FibroGen on matters concerning the product quality and CMO GMP compliance. This may include, but is not limited to:
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 FibroGen CMC Teams and functional management. Obtaining and communicating FibroGen?s deviation investigation requirements to CMOs and working with CMOs to investigate deviations until resolved.
Review equipment qualification protocols and reports.
Communication of changes between FibroGen 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.
Working with new CMOs to certify them as ready to begin manufacture of FibroGen?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.
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 FibroGen and FibroGen?s contractors.
Developing, refining, and managing internal FibroGen Quality Systems.
Bachelors degree in chemistry, biology, microbiology, industrial pharmacy or other related scientific discipline with a minimum of 7 years experience in QA oversight of pharmaceutical development and manufacturing.
Knowledge of cell culture and purification processing and associated batch record review of biologic manufacturing a must..
Experience with API and chemical drug product manufacturing QA oversight
Experience with QA oversight of manufacturing of both Clinical Trial Materials (CTM) and Commercial Products.
Practical knowledge of cGMPs and an ability to apply sound judgment and decision making skills (risk based and appropriate for the phase of clinical development) in order to evaluate product release.
Working knowledge of US and EU cGMP regulations and guidelines.
Experience in auditing suppliers and CMO?s
Strong planning and time management skills and ability to prioritize own work.
Strong leadership and influencing skills a must.
Knowledge of regulatory compliance of medical device manufacturing a plus.
Some travel required.
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