Quality Assurance – Manufacturing, GMP, CMC, Aseptic

Job Description: • Approve the final quality of Investigational Medicinal Products (IMPs) • Review and approve compliance with all mandatory requirements, including Manufacturing Batch Records, Environmental Monitoring (EM), Media Fills, deviations/violations/out-of-specification (OOS) events and corrective and preventive actions, packaging and labeling, drug release, distribution, and temperature control • Lead and manage all quality-related communications with regulatory authorities • Explain the sponsor’s quality system and release decision processes during regulatory inspections (e.g., EMA, FDA) • Provide scientific justification for the sterile product risk management framework within the Contamination Control Strategy (CCS) in accordance with Annex 1 • Ensure compliance with the Pharmaceutical Quality System (PQS) according to International Council for Harmonisation (ICH Q10) guidelines • Provide appropriate quality oversight of Contract Manufacturing Organizations (CMOs) • Approve change controls and Corrective and Preventative Actions (CAPAs) • Conduct quality risk assessments Requirements: • Minimum 10 years of Quality Assurance Management • Demonstrated experience managing quality for aseptic processing for a Pharma/Biotech or Contract Manufacturing Organization (CMO) • Experience performing cleanroom operations, aseptic techniques, contamination control, regulatory compliance, and environmental monitoring • Good Manufacturing Practices/Chemistry, Manufacturing, and Controls (GMP/CMC) expertise • Experience in critical risk assessment • Strong interpersonal and client-facing skills • Strong verbal and written communication skills in English required Benefits: • Registration with Advarra’s Expert Network required for consideration • Inclusive and collaborative environment • Empathy and care as key tenets of company culture • Commitment to creating a workplace where each person is valued