Position Summary:The Senior Director, GEM (Global External Manufacturing) Pillar Co-Lead serves Otsuka's global pharmaceutical business units by developing and leading global standard processes and systems to identify, select, contract and manage Contract Development and Manufacturing Organizations (CDMOs) across the life cycle of Otsuka biopharmaceutical products from early phase development through loss of exclusivity and removal from market. This leader will set the vision and be a hands-on mentor to ensure the company's external manufacturing network is cost-effective, reliable, and aligned with quality and regulatory requirements.The Senior Director role is responsible for setting the vision, strategic direction, expectations, annual and long-term objectives for the GEM function. They will serve as a scout for new CDMOs with which Otsuka may wish to partner on future compounds. - Additionally, the Senior Director partners with global affiliates and key stakeholders (e.g., business leaders) to execute global external manufacturing strategy, with the remit to achieve ongoing year over year improvements & reduce Otsuka's cost of doing business while maintaining/improving quality and adherence to regulatory guidelines. - This role will also serve to decide what needs to be escalated to the Global Pharmaceutical Production Strategy Committee (GPPSC) governance body.Key Responsibilities:
- Strategic Oversight:
- Accountable to develop standardized processes and approval templates for frequently executed activities (RFI, RFP, supply route approval, etc.).
- Build GEM into a high-performing, efficient and effective team.
- Develop and execute sourcing strategies for CDMO services across drug substance, drug product, and analytical services.
- Develop operating metrics and reports that provide Otsuka Senior Leadership with visibility into portfolio performance.
- Ensure contract templates are developed and maintained for frequently used contract types
- Develop decision matrices for key decisions (go/no go; timing; etc.) such as the implementation of an alternate or back up site
- In conjunction with the regional suppl chain teams, develop standards for business review meetings with CDMOs
- Partner with senior leadership in key manufacturing functions (Manufacturing, Supply Chain, CMC, GPQ), and Shared Services (Finance, Legal, and Procurement) to develop outsourcing models that support key business objectives.
- Focus on challenging the status quo to establish new ways of working faster and smarter, while delivering higher quality, increasing value and minimizing risk, especially regarding early phase clinical manufacturing and speed to clinic.
- Vendor Selection & Management Process
- Ensure there is alignment on contractual governance, annual and long-term objectives for the CDMO
- Develop and execute against a best-in-class contracting strategy that ensures industry competitive commercial contracts & rates with preferred vendor contracts
- Contracting & Budgeting:
- Collaborate on budgeting, forecasting, and cost-reduction initiatives related to outsourced manufacturing.
- Develop and manage a departmental budget within company targets
- Compliance & Risk Management:
- Ensure outsourcing activities comply with GMP, ICH guidelines, company SOPs, and all applicable regulations.
- Develop a process to identify outsourcing risks and develop mitigation strategies.
- Ensure compliance with corporate procurement policies and applicable regulatory standards.
- Ensure supply risk assessments and business continuity planning for critical outsourced activities are in place and sustainable.
- Leadership:
- Ensure operating model is appropriately structured to support business demand, including oversight of resource allocation and team performance
- Leads, teaches, coaches and directs Category/Sourcing professionals throughout the sourcing processes as well as key processes/skills (i.e., spend management analysis, stakeholder management, collaboration, process improvement, etc.).
- Support the roll out of key end to end enablement tools/systems, processes, and templates that will improve the buying channel experience.
- Responsible for the delivery of operations and general portfolio execution
- Monitor market trends, emerging suppliers, and innovations in outsourcing models.Qualifications and Preferred Experience:
- Bachelor's degree in Science, Engineering, Business, or related field (MBA or advanced degree a plus).
- 12-15+ years of experience in strategic sourcing or external manufacturing, preferably in pharmaceuticals or biotech. International experience essential.
- Proven ability to work with international colleagues.
- 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) along with EU, MHRA and other global health authority regulations.
- Strong negotiation, contract management, and supplier relationship management skills.
- Ability to influence and collaborate with cross-functional stakeholders in a matrixed organization.
- Excellent analytical, communication, and project management skills.