drjobs Senior Quality Manager

Senior Quality Manager

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1 Vacancy
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Job Location drjobs

Boston - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Responsibilities:

  • Manage daily quality oversight of 3PL providers and ensure compliance with regulatory expectations.
  • Maintain and support the Quality Management System (QMS) for distribution operations.
  • Prepare and maintain Quality Agreements.
  • Handle deviations CAPAs change controls and related documentation.
  • Conduct risk assessments and recommend mitigation strategies.
  • Maintain KPIs and support Management Review processes.
  • Support regulatory inspections including planning hosting and follow-up CAPAs.
  • Collaborate cross-functionally with internal stakeholders and external partners.
  • Review and approve SOPs and other Quality documentation.
  • Support product complaint handling and ensure suppliers are appropriately approved.
  • Oversee licensing activities and mock recall preparedness.

Requirements:

  • Bachelors degree in a scientific or allied health field.
  • 5 years of experience in Quality roles within pharmaceutical or life sciences.
  • In-depth understanding of GDP and GMP compliance standards.
  • Strong communication organizational and problem-solving skills.
  • Proficiency in Microsoft Office (Word Excel PowerPoint).
  • Auditing experience and qualifications are a plus.

Employment Type

Full Time

Company Industry

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