US-MA, PIER Document Manager SR0031809-MZ
The Manager will lead and drive the document revision and writing function supporting manufacturing projects and quality systems for changes and improvements (local site-based and/or cross-site) which involve general improvements, compliance needs, planning, and plant shutdowns.
The Manager will be responsible for the overall direction, coordination, implementation, execution, control and completion of manufacturing documents ensuring consistency with business strategy, commitments and goals. This includes defining, identifying and securing appropriate internal and external resources and coordinating the efforts of document writers in order to deliver documents according to plan. The individual will manage and oversee all aspects of manufacturing documents through the document lifecycles within the electronic documentation systems per applicable procedures, this will include creating and revising documents as driven by project needs, technical transfers and change management systems.
The Manager will lead and manage a group of document writers and represent the project management function to other partner groups, ensuring the quality of work and appropriate resourcing to support ongoing operations and projects.
50% Functional Management Responsible for performance management and professional development of direct reports who lead the lifecycle management of documents. Allocates resources, assigns priority to tasks and acts as an advisor to senior management in delivery of value-added services. Manages budgets and contract resources, as required.
50% Project Management Responsible for development of project management capability and provision of adequate resources (internally and externally) in the successful development, execution and delivery of documents for manufacturing operations compliance and continuous improvement projects. Accountable for effective delivery of documents in a robust, compliant, and cost-effective manner.
Education and Experience Requirements:
Bachelor s degree or equivalent experience in Engineering or Science and 8 plus (8+) years of relevant experience in commercial biotechnology or pharmaceutical production with prior experience managing people and schedule development is preferred.
Strong knowledge of cGMPs and applicability to manufacturing operations is required.
Excellent communication, technical, organizational, leadership, and mentoring skills are required. Must be a team player prepared to lead, work in, and embrace a team-based culture
Other Job Requirements
This position requires the ability to communicate clearly and accurately, verbally and in writing and a strong understanding and knowledge of manufacturing and compliance functions. Ability to work in a fast-paced environment and handle multiple tasks simultaneously. The candidate will be expected to evaluate and prioritize activities to support the business and add value to the company while understanding the specific priorities at the site.
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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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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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