Sr Manager, GxP Compliance Officer
Core
Ensures manufacturing sites and R&D Centers with US-FDA activities comply with US-FDA regulations (cGMPs, cGLPs, electronic records) and leads global compliance improvement efforts.
Role type
Senior Manager, GxP Compliance Officer
Builds
Compliance readiness for US-FDA inspections and global quality management processes
Domain
Pharmaceutical manufacturing and regulatory compliance
Required skills
US-FDA compliance expertise, GxP audit/inspection management, risk identification and remediation, strategy development for compliance gaps, training delivery, root cause analysis, project management
Preferred skills
Advanced degree in chemistry/molecular biology/microbiology/engineering, bilingual English/Spanish, established contacts with US-FDA
Technologies
None explicitly listed
Responsibilities
Lead global compliance activities and coordinate verification/tracking; Evaluate investigations and changes impacting regulatory commitments; Identify and remediate quality/compliance risks; Prepare sites for US-FDA inspections including mock inspections; Directly support US-FDA inspections and manage responses to FDA-483 observations; Develop strategies for new FDA cGMP trends; Prepare global quality management documents (SOPs)
Seniority
Senior Manager, strategic leadership and execution
