Quality Assurance Manager*in (m/w/d) Operations
Core
Ensure implementation and compliance of QA processes in ongoing GMP operations, supporting operational business and fostering a quality-oriented culture.
Role type
Quality Assurance Manager (Operations)
Builds
GMP-compliant quality management systems and processes for pharmaceutical manufacturing
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
GMP compliance, deviation management, risk management, CAPA management, change control, batch record review, customer complaint handling, root cause analysis
Preferred skills
Pharmaceutical manufacturing knowledge, chemical/biochemical/microbiological analytics
Technologies
GMP guidelines (EU-GMP, AMG, AMWHV), QMS tools
Responsibilities
Ensure QA process implementation and regulatory compliance; Provide on-site QA support to production and support areas; Act as local QA contact for operational departments; Manage deviations, risks, CAPAs, and change controls; Review batch documentation; Coordinate customer complaints and corrective/preventive actions; Train and support QA team members; Respond to GMP-relevant events and deviations on-site.
Seniority
Mid-Senior, hands-on IC
