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
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• 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