Compliance Officer
Core
Administers and maintains Quality Systems at a production unit from an FDA and global perspective, leading investigations into deviations and complaints to ensure regulatory audit readiness.
Role type
Senior IC compliance officer (pharmaceutical manufacturing)
Builds
Quality management systems and regulatory compliance frameworks for pharmaceutical production
Domain
Pharmaceutical manufacturing / Regulatory compliance
Required skills
Deviation investigation, root cause analysis, CAPA management, internal audit leadership, regulatory correspondence, trend analysis, cGMP knowledge, GAP analysis, risk assessment
Preferred skills
Technical writing, regulatory affairs experience
Technologies
FK gCMW KabiTrack systems
Responsibilities
Completes and reviews deviation investigations to define corrective actions; leads internal audit teams to inspect and remediate noncompliance; coordinates information collection for regulatory requests; supports compilation of annual product quality reviews; updates and maintains quality management systems; performs trend analysis on compliance data.
Seniority
Mid-level, hands-on IC
