Manager, QA Technical Operations
Core
Manager leading QA Technical Operations for Drug Substance, overseeing investigations, validation, qualification, and NPI/tech transfers in biopharmaceutical manufacturing.
Role type
Manager, QA Technical Operations (Drug Substance)
Builds
Drug Substance manufacturing processes and quality systems
Domain
Biopharmaceuticals / cGMP
Required skills
cGMP compliance, deviation management, change control, validation/qualification, NPI/tech transfer, regulatory interface, team leadership, cross-functional collaboration, risk management, process improvement, GMP documentation review
Preferred skills
SAP/MES/Maximo systems knowledge, global regulatory experience, coaching/mentoring
Technologies
SAP, MES, Maximo
Responsibilities
Own investigation system for MPCC, Warehouse, Automation, Engineering, Facility, Utility, and EM; manage investigation triage and daily meetings; support global harmonization of investigations; act as SME for Health Authority inspections; represent QA at IRB and Site Quality Council; approve complex multi-site investigations, deviations, and CAPAs; represent site at Global investigations COP and Local Process Owner meetings; support deviation recurrence prevention initiatives; drive Right First Time approach and KPIs; act as Senior Manager designee for QA huddles; lead QA for complex change controls, NPI, and Tech Transfer projects; lead cross-functional site and global QA projects; support maintenance of Maximo, MES, and SAP; support site validation and qualification activities; review and approve APQRs; hire, develop, and coach QA team members; drive continuous improvement and safe working practices; review and approve GMP documentation including plans, protocols, reports, SOPs, forms, directives, policies, and validation documentation.
Seniority
Manager, hands-on IC with team leadership