Manager, Quality Systems & Compliance - Deviation/CAPA/Complaints
Core
Lead a team of quality professionals to oversee deviation, CAPA, and complaints management programs ensuring regulatory compliance and operational excellence in pharmaceutical and medical device operations.
Role type
Manager, Quality Systems & Compliance (Deviation/CAPA/Complaints)
Builds
Quality management systems and regulatory compliance frameworks for pharmaceutical and medical device products
Domain
Pharmaceutical manufacturing and medical devices
Required skills
Deviation management, CAPA implementation, root cause analysis, regulatory compliance (cGMP, 21 CFR Part 211, ICH Q9/Q10), team leadership, cross-functional collaboration, audit support, quality metrics analysis, electronic quality management systems (TrackWise, Veeva Vault, MasterControl)
Preferred skills
Pharmaceutical manufacturing experience, medical device quality systems experience
Technologies
TrackWise, Veeva Vault, MasterControl
Responsibilities
Provide leadership and oversight of Deviation, CAPA, and Complaints programs; Lead and develop a team of quality professionals; Oversee deviation investigations and CAPA effectiveness checks; Monitor quality metrics and facilitate governance reviews; Collaborate with cross-functional stakeholders to resolve quality challenges; Support internal and external audits and regulatory inspections
Seniority
Manager, hands-on leadership