Director/Sr. Director, GMP QA
San Francisco, California, United States
Job type: fulltime
Job industry: Science & Technology
FibroGen (NASDAQ: FGEN) is seeking to change peoples' lives by bringing innovative therapies to life. We are motivated, curious, and passionate thinkers who believe in doing something truly important. Position Summary The Senior Director, Quality Assurance - GMPs will be responsible for directing all aspects of GMP compliance. This includes support for the manufacture of Drug Substance and Drug Products at Contract Manufacturing Organizations (CMOs) to ensure that FibroGen's drugs are manufactured in compliance with FibroGen Quality requirements, Good Manufacturing Practices (GMPs), 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 QA oversight of functional manufacture through clinical development and into commercial phase. Position Responsibilities This includes directing QA staff in: QA oversight of GMP CMOs and suppliers Interacting with CMO senior leaders to assure that FibroGen QA/GMP interests are met and that relationships are properly maintained Managing Quality Agreements with CMOs 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 fillings Preparation for and management of governmental regulatory agency inspections of FibroGen and FibroGen's contractors Developing, refining and managing internal FibroGen Quality Systems Position Requirements Bachelor's degree in chemistry, biology, microbiology, industrial pharmacy or other related scientific discipline with a minimum of ten years leadership experience in QA oversight of pharmaceutical development and manufacturing. Knowledge of small molecule oral solid dosage forms manufacturing a must. Experience with API and chemical drug product manufacturing QA oversight. Experience in large molecule technology and aseptic processing. Experience with Medical Device QA is preferred. 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 CMOs Strong planning and time management skills and ability to prioritize own work. Strong leadership and influencing skills a must. Ability to travel as required. FibroGen is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ ancestry, age, disability, marital, and veteran status. FibroGen will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.