Position Summary
Associate Director, Outsourcing & Vendor Governance (OVG) & Supplier Management—strategic oversight, governance, and performance management of external suppliers supporting the Technical Operations/CMC organization.
Responsibilities
- Own supplier management strategy for CMOs, CDMOs, testing labs, depots, raw material suppliers, and other external service providers.
- Establish governance models (operating frameworks, performance reviews, escalation pathways) and ensure alignment with program timelines and technical/business needs.
- Serve as primary Technical Operations contact for strategic external suppliers.
- Lead negotiations for Technical Operations contracts, amendments, and scope changes (with Procurement and Legal); negotiate pricing, timelines, capacity, change orders, and service levels.
- Manage supplier performance using KPIs/SLAs/quality and run regular business reviews for risks and continuous improvement.
- Partner cross-functionally (CMC, Quality, Supply Chain, Finance, Procurement) for supplier selection/onboarding/lifecycle management; support outsourcing strategies and make-vs-buy decisions.
- Ensure supplier compliance with GMP/GxP/regulatory requirements; support audits/inspections and quality agreements; identify compliance/capacity/business continuity risks.
- Support budget planning, forecasting, and tracking of external supplier spend; monitor cost drivers and scope/financial risks; drive cost optimization.
Required Qualifications
- Bachelor’s degree in Science/Engineering or related field.
- 12+ years in CMC/Technical Operations/external manufacturing/outsourcing/supplier management (pharma/biotech).
- Experience managing external suppliers/CMOs/CDMOs across development and/or commercial manufacturing.
- Strong GMP/GxP/regulatory knowledge.
- Ability to manage complex multi-supplier environments and cross-functional stakeholders.
Preferred Qualifications
- MS/PhD/MBA.
- Clinical and commercial CMC program experience.
- Familiarity with supplier governance models, KPIs, and risk management frameworks.
- Strong negotiation, influence, and executive communication.
Benefits / Total Rewards (as stated)
- Discretionary annual target bonus; stock options; ESPP; 401k match.
- Medical, dental, vision, basic life insurance; 20 days PTO; 10 paid holidays; winter company shutdown.