Shire Quality Assurance Manager - Disposition in Lexington, Massachusetts

The role is accountable for disposition activities with the QA Disposition group supporting the Lexington Site within the Biologics Operating Unit

The scope of operations performed in support of manufacturing activities includes:

  • cell bank

  • unpurified bulk (UPB)

  • drug substance (DS) disposition

  • management of quality systems from initiation to closure (deviations, investigations, CAPAs, change controls, etc.)

This position will be responsible for:

  • Timely disposition of UPB and DS in line with global regulatory expectations and Shire standards.

  • Working with cross functional groups in each department supporting manufacturing operations within the Lexington Site organization.

  • Ensuring consistency and communication, where appropriate, across the manufacturing operating sites.

This individual will partner closely with the following groups to ensure timely disposition of intermediates and products:

  • Quality Assurance groups

  • Quality Control

  • Manufacturing

  • Compliance

  • Materials Management

  • Regulatory

  • Supply Chain

Experience:

  • Minimum of 5 years experience

  • Ideally within Pharma or Medical Device

  • Strong collaboration skills

  • Ability to communicate effectively, both written and verbal, with leadership

  • Strong Project Management skills

  • Ability to effectively work with cross functional groups

  • Degree Required

Notice to Employment / Recruitment Agents:

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Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, 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 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.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.