Associate Director, CDMO Strategic Sourcing Job at Otsuka Pharmaceutical Co. in

Position Summary:

The CDMO Strategic Sourcing Director will be responsible for supporting the development and executing sourcing strategies for Contract Development and Manufacturing Organizations (CDMOs) to support drug development and commercial manufacturing. This leader will manage supplier relationships, lead cross-functional sourcing initiatives, and ensure the company's external manufacturing network is cost-effective, reliable, and aligned with quality and regulatory requirements.

Under the direction and guidance of the Senior Director, CDMO Strategic Sourcing, GEM, the Associate Director will partner within the Global External Manufacturing (GEM) team to co-lead the process for the selection of CDMOs. The Associate Director will also serve as the lead for contract negotiations for global CDMOs in partnership with the business units.

Key Responsibilities:

• Vendor Selection & Management Process
  • Support with the development and execute sourcing strategies for CDMO services across drug substance, drug product, and analytical services.
  • Identify, evaluate, and select CDMO partners for preclinical, clinical, and commercial stage programs.
  • Lead contract negotiations, including pricing, service levels, and intellectual property terms.
  • Partner with Technical Operations (CMC, Clinical Supplies & Clinical Manufacturing), Quality, Regulatory, and Supply Chain teams to ensure supplier capabilities meet program needs.
  • Manage key CDMO relationships to ensure performance, mitigate risks, and drive continuous improvement.
  • Monitor market trends, emerging suppliers, and innovations in outsourcing models.

• Contracting & Budgeting:
  • Oversee development and negotiation of Master Services Agreements (MSAs), Statements of Work (SOWs), and Change Orders (COs).
  • Collaborate on budgeting, forecasting, and cost-reduction initiatives related to outsourced manufacturing.

• Compliance & Risk Management:
  • Identify outsourcing risks and develop mitigation strategies.
  • Ensure compliance with corporate procurement policies and applicable regulatory standards.
  • Lead or support supply risk assessments and business continuity planning for critical outsourced activities.

Qualifications and Preferred Experience:

• Bachelor’s degree in Science, Engineering, Business, or related field (MBA or advanced degree a plus).
• 8–12+ years of experience in strategic sourcing or external manufacturing, preferably in pharmaceuticals or biotech. International experience essential.
• Deep knowledge of CDMO landscape and manufacturing processes (e.g., small molecule, biologics, sterile fill-finish, etc.).
• Thorough knowledge of GMPs (CFR title 21, parts 210-211 and Part 600 ), GCPs (current Good Clinical Practices) and EU regulations regarding clinical studies
• Strong negotiation, contract management, and supplier relationship management skills.
• Ability to influence and collaborate with cross-functional stakeholders in a matrixed organization.
• Experience with quality and regulatory standards (e.g., cGMP, FDA, EMA).
• Excellent analytical, communication, and project management skills.