QA Operations Manager
Core
Ensure sterile products (NPI and Commercial) are manufactured, filled, and released in compliance with regulatory requirements for patient safety and efficacy.
Role type
Senior IC QA Operations Manager (Pharmaceutical Manufacturing)
Builds
Sterile and aseptic drug products for commercial and clinical use
Domain
Pharmaceutical manufacturing / Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, batch release, product transfer management, regulatory authority liaison, audit management, process validation, aseptic filling oversight, visual inspection oversight, sterilization operations oversight, marketing authorization verification
Preferred skills
Supervisory and managerial experience, FDA and EMA approved environment experience, industrial pharmaceutical science background
Technologies
EU GMP Annex 1, FDA regulations, Directive 2001/83/EC
Responsibilities
Ensure NPI and Commercial Products meet relevant GMPs; manage oversight for effective product transfer of NPIs to commercial manufacturing; manage site QPs and Manufacturing Quality Assurance including batch release; verify batches comply with marketing authorisation provisions; confirm production changes are authorized; liaise with global QA, Regulatory groups, FDA, and HPRA; ensure effective transfer of NPIs to site and progress into clinical/commercial manufacturing; work with QA Director to meet customer, quality, regulatory, and financial goals.
Seniority
Senior, hands-on IC with management oversight
