QA Operations Manager
Core
Provide quality oversight and technical support for GMP manufacturing activities performed by Contract Manufacturing Organizations (CMOs) to ensure compliance with cGMP regulations and internal quality systems.
Role type
Quality Operations Manager (GMP oversight)
Builds
GMP-compliant drug substances and products manufactured by external CMOs
Domain
Biopharmaceuticals / cGMP Manufacturing
Deliverable
client delivery
Required skills
GMP compliance assessment, deviation investigation, change control evaluation, batch record review, risk assessment, regulatory knowledge (FDA/EU/ICH), cross-functional collaboration, process validation support, continuous improvement, technical mentorship
Preferred skills
Experience with electronic quality management systems (eQMS), knowledge of 5 Whys and fishbone analysis methodologies
Technologies
Electronic Quality Management Systems (eQMS)
Responsibilities
Review and approve quality records for CMO-manufactured GMP products; Support batch disposition activities and quality decision-making; Conduct deviation investigations and root cause analysis; Provide input into change control activities; Participate in internal and external audits; Support new product introductions and technology transfers; Mentor less experienced colleagues
Seniority
Mid-Senior, hands-on IC
