Posted to MedZilla on 2/22/2020

Takeda Pharmaceuticals

US-MA, Lead Device Supplier Relationship & External Operations SR0045171-MZ


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.)

Responsibilities Include:

  • 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

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Pay Transparency Policy -

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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