The Sr. Project Manager is directly responsible for the management and oversight of Manufacturing Operations projects at the Lexington site. The position is responsible for managing cross-functional project teams to on-plan completion of assigned projects, including financial performance. This position will support site and departmental goals through the alignment of projects with the organization s vision, strategic, and capital plan.
70%: Project Manager
Sets the project strategy, schedule, aligns resources and provides ongoing analysis of financial and schedule performance.
Develops project execution plans, identifies staffing requirements (internal and external) and develops project budgets
Drives use of Takeda's Project Management Methodology throughout projects.
Leads the project team in defining program strategies and goals, and assigns/manages project tasks to ensure the project team meets all commitments.
Develops and maintains project schedule and budget
Develops and manages team deliverables/documents required for successful project completion, including URS, scope of work, design documents, change controls, SOPs, commissioning and validation protocols, etc.), ensures development and approval.
Responsible for initiation of change control or other quality system requirements associated with projects as necessary
Manages deployment of resources to efficiently execute tasks, including project meeting management.
Manages contract, vendor and service suppliers as necessary.
Develops project reports and makes presentations to governance teams and project sponsors
Provides clear direction on product/process development requirements and facility/equipment upgrades required to meet expectations of customers and stakeholders.
Communicates project status updates to all levels of management.
Anticipates and proactively resolves conflict situations to ensure win-win outcomes.
Manage all project requirements including engineering design, equipment evaluation and procurement, contractor selection and coordination of all project resources to ensure successful project execution, validation and handover to manufacturing.
Demonstrates a commitment to continuous improvement of Lexington PMO business processes
25%: Project Planning
Works with project sponsors to build a project team and assign individual responsibility levels. Identifies project objectives and business drivers
Collaborate with project portfolio manager, operational excellence and site leadership teams on project identification, chartering and scoping
Presents charters and project plans to governance bodies
Provide budgetary, resource and schedule estimates for the requirements of projects
Plan and initiate projects
5%: Develop and Maintain Project Management Standards / Templates
Utilize and collaborate with corporate project/program management offices on corporate project management standards, processes and policies
Promotes compliance with all corporate, safety and cGMP standards, procedures and policies.
Assists in developing and maintaining departmental policies and procedures
Education & Experience Requirements:
Bachelor s degree and PMI certification required.
MS, MBA, PE license or professional registration a plus.
Degree in Engineering or Science preferred.
Minimum 7 - 10 years of professional experience and 5+ years of project management experience required.
Experience in FDA regulated environment preferred
Other Job Requirements:
Limited travel (domestic and international) required.
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 - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.