The Lead Device Supplier Relationship & External Operations manages supplier relationships within the Medical Device Center of Excellence (MD CoE) organization to achieve Takeda s objectives and in close coordination and collaboration with Procurement, Tech OpU (for Combination Products) and other shared services (Legal, Planning etc.)
- Lead the day to day business relationship between our external device suppliers and internal team members both within and outside of our MD CoE group
- Lead and be accountable for supplier agreements and contracts such as CDA, NDA, MSA, SOW, Quality agreement, and other supplier agreements
- Follow business processes and guidelines to act as the center of excellence for legal and financial aspects of the alliance
- Contribute to negotiation of contract terms and conditions, including the management of amendment activities.
- Contribute to tactical and strategic sourcing activity identifying and selecting strategic partners
- Prepare and facilitate proper meeting cadence with suppliers such as quarterly business review, steering committees, and other meetings as appropriate
- Work closely with technical teams and manage supplier issue escalation and obstacles
- Develop and monitor KPI, generate monthly reports, track issues
- Manage multiple scopes of work in support of the medical device objectives
- Ability to travel domestically and internationally up to 20+%
Responsibilities: 40% of the time;
- Lead and be accountable to CDA, NDA, MSA, SOW, Quality agreement, and supplier agreements
- Work with cross functional technical team to develop and monitor short-term and long-term supplier performance to timelines, forecasts, and scopes.
- Partner with Takeda stakeholders to select among existing or develop new partners who can meet program requirements and augment Takeda internal or external manufacturing network capabilities
- Manage existing supplier business relationships, including proper meeting cadence
- Particpate in make vs buy analyses with the cross functional team and Device Development Leads (DDLs), as needed
- Develop and strengthen mutually beneficial relationships with members of Takeda's CMO network
- Coordinate with Tech Ops OpU SRM to convey device priority and planning
30% of the time;
- Work with peer groups to develop targets for the suppliers' KPI dashboards working with the cross functional team
- Monitor performance of the suppliers and serve as primary point of escalation for issues/KPIs.
- Review KPIs with suppliers and internal teams (consider customer survey)
- Participate in the implementation of CAPAs. Communicate changes and issues with suppliers
- Participate in major projects to improve supplier performance and continuous improvement projects
- Track, monitor, and report performance metrics related to operations, quality, cost, and customer service.
- Develop and distribute periodic reports on CMO performance, issues, risks, and schedules of key activities, events, or milestones.
15% of the time;
- Clinical and commercial device planning (logistics, ordering, challenges, proactive plans)
- Work with other DDL s to ensure that technology, operations, and quality expectations are accurately represented in requests for proposals, and then reflected in subsequent contracts and agreements with CMO's.
- Proactively identify CMO activity-related risks that may impact Takeda program commitments: supply delivery dates, program milestones, or goals.
- Work with CMO's, DDL's and cross-functional business partners to develop robust mitigation and contingency plans.
- Identify, elevate, and work with Takeda stakeholders and CMO's to help execute SOWs and facilitate resolution of issues that may arise.
- Monitor and work to ensure that Takeda's expectations and goals for regulatory compliance, product quality, and production (e.g. cost, cycle-times, yield, etc.) are consistently met for the programs
15% of the time;
- Monitor and drive adherence to Takeda's and CMO contractual commitments, obligations, and processes, including milestone dates, financial terms, and production schedules both internally and externally.
- Supports implementation of Continuous Improvement initiatives (including Lean Sigma) at suppliers/CMO's
- Participate in lesson learned reviews at least at the following milestone achievements: (Contract signed,Feasibility assessment competed,Regulatory filling readiness,1st Launch (1st major geography US, EU)
- Performs other assignments as requested by the MD CoE leadership team
- Comply with appropriate legislation and Takeda policies including, but not limited to: Sarbanes Oxley, Environmental Safety & Health, and Corporate Responsibility
Education and Experience Requirements:
- Bachelor/ Master Degree in Engineering, Biotechnology, Business or scientific field
- Minimum of 8 years relevant clinical/commercial Pharmaceutical experience
- Strong business development, project management, problem solving, decision making, collaboration, influence, and facilitation skills.
- Experience leading cross-functional teams to overcome hurdles and deliver project results on time and as expected.
- Interpersonal skills necessary to develop effective working relationships with internal stakeholders, CMOs, and represent the External manufacturing organization on cross-functional and cross-cultural project teams.
- Understanding of biotech/pharma manufacturing operations, product and process development, and supply chain operations
- Ability to effectively communicate and persuade others at every level to accomplish challenging tasks
- Demonstrable cGMP Manufacturing knowledge working in a cGMP manufacturing environment
- Knowledge in FDA & EU device/combination product development requirements
- Able to negotiate and manage contracts
- Experienced in risk management processes
Key Skills, Abilities, and Competencies Minimum:
- Excellent verbal, organizational, written, and interpersonal skills
- Proven cGMP experience
- Ability to work in a high performance culture
- Ability working under tight timelines
- Adapts quickly to shifting priorities and rapid change
- Self-starter and can work autonomously
- Remains focused with the Product Team initiatives
- Demonstrates tolerance for ambiguity and uncertainty
- Demonstrated strategic thinking
- Ability to manage business results and champion change
- Collaborates well with other areas of the business - Team Player
- Ability to manage and resolve conflicts
- Demonstrated leadership capability and skills
- Negotiation skill to achieve agreements with suppliers
- Contribute to the development and maintenance of the Supplier Strategy
- Obtain local and global market intelligence - understand supplier capabilities and market dynamics
Advanced /added Plus:
- 10+ years of relevant experience.
- MBA, Master or higher degree in a relevant Science or Engineering discipline.
- Extensive personal network of contract manufacturers and business contacts.
- Direct experience leading multidisciplinary cross-cultural teams conducting CMO tech transfers, trouble shooting, validation, and clinical/commercial ongoing manufacturing.
- Strong contract negotiation, contract administration, and financial skills.
- Demonstrated experience working with multiple international business partners.
- Strong business and functional knowledge of biopharmaceutical and/or pharmaceutical Operations, Process Development, Finance, Supply Chain Management, Regulatory Affairs, Quality Assurance, and Quality Control.
- Lead commercial negotiations and provide strategic and tactical commercial input to Lifecycle
- Management / Project Teams (new suppliers)
- Lead / participate in feasibility studies and global sourcing enquiries. Prepare RFX s, obtain and evaluate cost proposals / quotations
- Create Confidentiality Disclosure Agreements (CDA s) and Commercial Contractual
- Additional language skills will be an asset
Complexity and Problem Solving:
- Superior negotiation skills, ability to avoid and resolve conflicts
- Sound technical understanding with relation to cGMP
- Able to deal with and resolve complex problems which may affect more than one product / site
- Must understand marketplace and various global related regulations
- Manage a wide range of problems that require complex judgments and innovative solutions in order to meet the needs of both Takeda Product/ Technical Teams and the external supplier
- Skilled and experienced at handling complex negotiations both with and on behalf of internal customers within a matrix organization
Internal and External Contacts:
Internal Contacts: Device Development Leads,Product Teams,Procurement,Legal, Tech OpU,Functional Leaders (Regulatory, Quality, Technical),Governance Team Members,Device functions, MD CoE Leadership Team
External Contacts:Suppliers,Consultants,Industry benchmark contacts
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