Key skills
LeadershipRisk ManagementTeam LeadershipCommunicationNegotiation
About this role
Role Overview
- Lead external quality management and oversight of third-party manufacturing partners and CMOs
- Serve as the Quality point of contact for external partners and internal stakeholders
- Lead external manufacturing Quality team in Mexico and Canada for review, packaging and release for all local and imported products
- Ensure partner compliance with GMP requirements, Quality Agreements, and commercial commitments
- Oversee batch review, product release, change control, validation, audits, and remediation activities
- Support quality system improvement, risk management, and continuous improvement initiatives
- Manage team performance, budget, and headcount planning
- Partner cross-functionally to support operational excellence, compliance, and supply continuity
Requirements
- 10+ years of experience in a pharmaceutical company and/or External Manufacturing Organization
- 2+ years of direct people leadership experience
- Proven remote management, team leadership, and performance accountability skills
- Strong background in Quality Systems, QA/QC, global GMP, and regulatory requirements
- Demonstrated experience in external quality management and third-party oversight
- Strong problem-solving, risk management, communication, negotiation, and influencing abilities
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays, vacation, and compassionate and sick days