Job Description
- 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
Apply tot his job
Apply To this Job