Sr. Procurement Manager needed in Waltham, MA!
Summary:
The Sr. Procurement Manager – CMC, Quality & Supply Chain is responsible for executing and supporting strategic sourcing and procurement activities across Chemistry, Manufacturing & Controls (CMC), Quality Assurance, and Supply Chain. This role supports category strategies and manages sourcing activities across key areas including CDMOs, API and drug product manufacturing, raw materials, GMP services, and quality systems.
This position supports Technical Operations to ensure supply continuity, regulatory compliance, and cost-effective procurement in a highly regulated, outsourced manufacturing environment.
Key Responsibilities:
- Support and execute category strategies for CMC, Quality Assurance, and Supply Chain in alignment with clinical and commercial program needs
- Execute sourcing activities and support supplier selection for key categories, including CDMOs, API/drug substance and drug product manufacturing, raw materials, and GMP service providers
- Partner with CMC, Quality, Regulatory, and Supply Chain teams to support product development, tech transfer, validation, and commercialization activities
- Negotiate and manage contracts (e.g., MSAs, Quality Agreements, Supply Agreements, Statements of Work) with a focus on risk mitigation and compliance
- Support supplier relationship management, including performance tracking, quality metrics, and issue resolution
- Ensure procurement activities adhere to GxP requirements and support audit and inspection readiness
- Identify and escalate supply risks, including single-source dependencies, capacity constraints, and supply chain disruptions
- Support supply planning alignment, inventory strategies, and lifecycle management in partnership with Supply Chain
- Contribute to cost savings and value initiatives while balancing quality, compliance, and speed-to-clinic/market priorities
- Support cross-functional initiatives related to supplier governance, process improvements, and procurement systems
- Provide guidance to junior team members and contribute to building scalable procurement processes
Qualifications:
- Bachelor’s degree in Supply Chain, Business, Life Sciences, Engineering, or related field (advanced degree preferred)
- 8–12+ years of procurement/sourcing experience, with significant experience supporting CMC, Quality, or Supply Chain in pharma/biotech
- Experience supporting outsourced manufacturing models, including CDMO engagement
- Experience negotiating and managing contracts, including MSAs, Quality Agreements, and Supply Agreements
- Working knowledge of GxP requirements and supplier compliance expectations
- Proven ability to collaborate effectively with technical and quality stakeholders in a regulated environment
- Experience with ERP and procurement systems (e.g., SAP, Coupa, Ariba)
Preferred Qualifications:
- Experience supporting clinical-stage and/or commercial biopharma programs
- Familiarity with CMC regulatory requirements (IND, NDA/BLA submissions)
- Exposure to supplier audits and quality systems
- Professional certifications (e.g., CPSM, CSCP)
Leadership Competencies:
- Strong execution and operational focus
- Business and regulatory awareness
- Collaborative and cross-functional mindset
- Risk awareness and sound judgment
- Ability to operate effectively in a fast-paced biotech environment
