Role Summary
Sr Manager Global Procurement. Oversees a team that supports and maintains all cGMP compliance aspects of procurement operations, including management of the Approved Supplier List, deviation investigations, CAPAs, supplier audit closures and evidence follow-up, regulatory inspections support, SOP writing and revision, change controls, and SCAR management processes. Additional compliance tasks may be assigned.
Responsibilities
- Ensures the team operates as a global cohesive unit across all IOPS sites, achieving efficiencies and compliance.
- Tracks progress on Strategic Sourcing & Procurement quality system deliverables, including deviation investigations, CAPAs, change controls, and documentation due dates.
- Interfaces with Quality Assurance and other functions to resolve obstacles and facilitate decisions on quality system deliverables.
- Monitors, reports, and responds to KPIs for compliance functions (e.g., right-first-time for deviation investigations).
- Performs deviation investigations and coordinates CAPA implementation for high-risk events.
- Maintains procurement cGMP procedures, documentation, and training related to SOPs and Work Instructions.
- Reassesses Strategic Sourcing & Procurement systems for adherence to cGMPs and implements improvements.
- Represents the department during regulatory inspections and coordinates responses to inspection observations.
- Supports start-up/integration of procurement compliance functions at other sites, including travel as needed.
Qualifications
- Required: Bachelorโs degree
- Required: 8+ years of relevant experience, with at least 5 years in a cGMP environment or an equivalent combination of education and experience
Skills
- cGMP compliance and regulatory inspection support
- Supplier management and ASL oversight
- Quality system deliverables, deviation investigations, CAPAs, and change controls
- Audit coordination and evidence gathering
- Proficiency with SOPs, Work Instructions, and master service/quality agreements
Education
- Bachelorโs degree (required)