Associate Director, CDMO Strategic Sourcing
Otsuka Pharmaceutical Companies (U.S.) · United States
- Hybrid
- Full-time
- $180,000 / year
- United States
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Job highlights
- Develop and execute CDMO sourcing strategies.
- Lead contract negotiations and supplier selection.
- Manage supplier relationships and mitigate risks.
- Ensure quality and regulatory compliance.
- Collaborate with cross-functional teams globally.
About the role
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.
Competencies
- Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
- Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
- Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
- Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
- Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
- Empowered Development - Play an active role in professional development as a business imperative.
Key skills/competency
- Associate Director, Strategic Sourcing
- CDMO Sourcing
- Contract Negotiation
- Supplier Relationship Management
- Pharmaceutical Manufacturing
- Biotech Outsourcing
- GMP Compliance
- Regulatory Standards
- Risk Management
- Supply Chain
Skills & topics
- Associate Director
- CDMO
- Strategic Sourcing
- Pharmaceutical
- Biotech
- Contract Negotiation
- Supplier Management
- External Manufacturing
- GMP
- Global Sourcing
How to get hired
- Tailor your resume: Highlight strategic sourcing, CDMO experience, and negotiation skills.
- Showcase pharma/biotech expertise: Emphasize knowledge of GMPs, GCPs, and regulatory standards.
- Demonstrate international experience: Detail your work with global CDMOs and cross-functional teams.
- Prepare for behavioral questions: Use STAR method to illustrate problem-solving and collaboration.
- Research Otsuka: Understand their values and commitment to patient-centricity.
Technical preparation
Master GMP, GCP, and relevant regulations.,Understand small molecule and biologic manufacturing.,Practice negotiation and contract drafting.,Analyze supplier capabilities and market trends.
Behavioral questions
Describe a complex sourcing challenge resolved.,How do you ensure cross-functional alignment?,Give an example of strategic risk mitigation.,How do you drive continuous supplier improvement?
Frequently asked questions
- What is the typical career progression for an Associate Director, CDMO Strategic Sourcing at Otsuka Pharmaceutical?
- The Associate Director role at Otsuka Pharmaceutical offers a strong foundation for advancing within strategic sourcing and external manufacturing. Typically, progression could lead to a Senior Director position, focusing on more complex global strategies and team leadership, or potentially moving into broader supply chain or operations management roles within the pharmaceutical sector. Your growth will be supported by continuous learning and demonstration of leadership in key competencies like strategic thinking and accountability.
- What are the key differences between this Associate Director role and a Senior Director role in CDMO Strategic Sourcing at Otsuka?
- As an Associate Director, you will co-lead CDMO selection and lead contract negotiations, with direct support and guidance from the Senior Director. A Senior Director would typically have ultimate accountability for the overall sourcing strategy, manage a larger portfolio of critical suppliers, and may have direct reports. The Associate Director role is more focused on execution and partnership, while the Senior Director role encompasses broader strategic oversight and leadership.
- How important is international experience for the Associate Director, CDMO Strategic Sourcing role at Otsuka?
- International experience is essential for this Associate Director role. Otsuka operates globally, and managing CDMO relationships and negotiations often involves diverse international partners and regulatory landscapes. Your ability to navigate cross-cultural communication, understand global market trends, and manage contracts with overseas suppliers will be critical to success.
- What specific manufacturing processes knowledge is most valuable for an Otsuka Associate Director, CDMO Strategic Sourcing?
- The role requires deep knowledge of various CDMO manufacturing processes relevant to Otsuka's pipeline. This includes expertise in areas such as small molecule synthesis, biologics development and manufacturing, sterile fill-finish operations, and analytical services. Demonstrating familiarity with the specific challenges and quality requirements of these diverse processes will be highly advantageous.
- How does Otsuka Pharmaceutical ensure quality and regulatory compliance in its external manufacturing partnerships?
- Otsuka Pharmaceutical places a strong emphasis on quality and regulatory compliance. The Associate Director role involves close partnership with Technical Operations, Quality, and Regulatory teams to ensure CDMO capabilities meet stringent standards. This includes thorough due diligence on potential partners, rigorous contract management with built-in quality clauses, and ongoing monitoring of supplier performance against GMPs, GCPs, and other relevant global regulations.