Senior Manager, External Partners Oversight
Core
Provide leadership and direction for evaluating external suppliers to ensure compliance with worldwide regulatory requirements, quality, and safety standards for medical devices and drug development.
Role type
Senior Manager, External Partners Oversight
Builds
Quality Agreements and supplier oversight programs for medical device and drug development suppliers
Domain
Life Sciences / Pharmaceutical / Medical Device / Regulatory Compliance
Deliverable
client delivery
Required skills
Supplier oversight, GxP regulations (GMP, GLP, GCP, GDP, GCLP), Medical Device regulations, Quality management systems, Project management, Cross-functional collaboration, Metrics analysis
Preferred skills
Quality Assurance/Regulatory Affairs experience, Compliance/auditing, Laboratory experience, ASQ CQM/CQA certification
Technologies
Quality management systems, Regulatory databases
Responsibilities
Assess compliance with applicable regulations through supplier oversight activities; Interpret and apply governmental regulations, guidelines, policies, and procedures; Manage Quality Agreement life cycle including creation, review, and termination; Collaborate with R&D to resolve external supplier quality issues; Collect, analyze, and report metrics pertaining to External Partners Quality; Lead or participate in strategic initiatives to improve compliance to regulatory requirements
Seniority
Senior, hands-on IC with leadership responsibilities
