Sr Manager, GxP Compliance Officer
Core
Ensures manufacturing sites and R&D Centers comply with US-FDA regulations (cGMPs, cGLPs, electronic records) for global facilities importing API or finished products to the US market.
Role type
Senior Manager, GxP Compliance Officer
Builds
Compliance strategies, mitigation plans, and readiness for US-FDA inspections
Domain
Pharmaceutical manufacturing and regulatory compliance
Deliverable
client delivery
Required skills
US-FDA compliance expertise, risk management, root cause analysis, audit/inspection management, process harmonization, strategic planning
Preferred skills
GxP audit execution, bilingual English/Spanish, established US-FDA contacts
Technologies
Quality Management Systems
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 and conduct mock inspections; Participate in and support US-FDA inspections; Develop strategies for new FDA cGMP trends; Prepare global quality management documents
Seniority
Senior, hands-on IC with team leadership
