Shire Manager, QA Validation in Cambridge, Massachusetts

Primary Role: The individual will provide QA oversight of Validation activities at Massachusetts Biologics Operations site. The activities include, but are not limited to, the following areas: Provide quality oversight to Validation programs, inclusive of validation plans, schedules and operational activities at Alewife Provide quality oversight of facility and equipment commissioning and qualification activities Provide technical assessments on change controls, deviations and investigations, assessing proposed changes to validated processes to identify requirements necessary to maintain validated status. Support cleaning validation efforts. Provide guidance to other staff members in the oversight of protocols and other documentation for cell banking, cell culture and purification processes. Provide quality oversight of engineering and validation studies, as well as data analysis and compilation of data and results into summary and final reports. Use project management skills to drive results and achieve expected timelines and outcomes Represent the QA-Validation team on project core teams and participate in strategy discussions aligned with global initiatives and regulatory requirements. Support and interface with global PPQ community of practice where needed to ensure alignment and consistency with global practices Provide technical support for product / process transfers into and out of the Alewife site Support regulatory inspections and inspection readiness activities

Responsibilities: 80%: Manage, advise on strategy and review protocols, reports and other relevant documents in the following areas: Tech transfer (new product introduction) Change management Continuous lifecycle management Manage and review assessments for the following Quality System elements for: Quality Risk Management program Quality Project Plans Change Controls Participate and contribute in design, development and validation strategy: Provide technical input to strategy/philosophy for qualification activities Participate on cross-functional/cross-site teams

15%: Identify opportunities for continuous improvements, participate in the deployment of best practices, represent QA Validation at cross-site/cross-functional alignment teams and support the communications boards and communities of practice.

5%: Participate in regulatory agency inspections.

Education and Experience Requirements: Bachelor's or Master’s degree in Biology, Chemistry, Chemical Engineering or related field with a minimum of 8 years relevant experience in the biotechnology and/or pharmaceutical industry. Knowledge of industry regulations and guidances related to Validation, and a working knowledge of statistical analysis and root cause analysis is required Excellent interpersonal skills and strong oral and written communication

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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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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.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.