15 days old

Quality Manager

Shire Human Genetic Therapies, Inc.
Lexington, MA 02421
  • Job Code
    R0037013

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Manager in our Lexington, MA office.

OBJECTIVES/PURPOSE

  • This disposition team is accountable for batch disposition for Biologics product manufactured at CMOs on behalf of Takeda.
  • The scope includes Drug Substance, Drug product and Finished Drug Product
  • This disposition team will work with our external CMO partners and internal Quality teams within this department .In addition this functions works closely with External Supply , Supply Planning, Technical support and any stakeholders involved in external supply.

ACCOUNTABILITIES

  • Reviewing batch documentation, data, certificates of analyses, technical reports and providing support to Quality Disposition personnel
  • Dispositioning batches in alignment with Takeda Quality Systems and GMP regulations
  • Managing, designing and implementing quality systems relating to batch disposition
  • Maintaining and improving quality metrics that incorporate continuous improvement methodologies
  • Facilitating, approving and providing inputs into deviation investigations, change controls, CAPA, investigations and nonconformance reviews as required
  • Managing batch disposition processes as required

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

  • 8 + years experience working in manufacturing and/or Quality to support the manufacturing of biologic products. Must have experience in batch disposition.
  • Thorough understanding of quality systems and cGMPs.
  • Experience conducting audits and/or involvement in preparation for Health Authority inspections.
  • Interpersonal skills and communication skills to interact with CMO partners and other functions.
  • Must be able to prioritize in a busy environment.
  • Must be able to travel up to 5% (domestic)
  • Must be fluent in English

This job posting excludes CO applicants.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-06-07 Expires: 2021-07-06
Sponsored by:
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Sponsored by:
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Quality Manager

Shire Human Genetic Therapies, Inc.
Lexington, MA 02421

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