Senior Manager Quality Assurance (m/w/d)
Core
Leading and optimizing Quality Assurance operations, compliance, and team management in a sterile pharmaceutical manufacturing environment.
Role type
Senior Manager, Quality Assurance (Sterile Pharma)
Builds
Quality systems, compliance frameworks, and audit readiness for sterile operations
Domain
Pharmaceutical manufacturing (Sterile) + Regulatory Compliance (GMP)
Required skills
GMP regulations (EU Annex 1, ICH Q9/Q10, FDA cGMP), CAPA management, Change Control, Risk Management, Team Leadership, Audit Management, Regulatory Documentation, Sterile Operations Knowledge, Customer/Authority Relations
Preferred skills
Strategic project leadership, Cross-functional collaboration, Process optimization
Technologies
GMP software suites, CAPA tools, Quality Management Systems (QMS)
Responsibilities
Lead and develop a QA team of 3 direct and 25 indirect reports; Optimize processes for deviation, CAPA, change control, and complaint management; Ensure compliance with EU-GMP, Annex 1, ICH, and FDA cGMP requirements; Prepare and accompany customer audits, self-inspections, and regulatory inspections; Support technical departments on GMP-related issues in sterile operations and analytics.
Seniority
Senior, hands-on IC with management responsibilities