Quality Management Associate Director

New

Skills

Audits CAPA Management Change Control GxP Compliance Internal Audits Quality Management Systems Regulatory Submissions Supplier Management Team Leadership Veeva QMS

We are seeking an experienced Associate Director of Quality Management Systems to lead global Quality Systems and ensure GxP compliance. This role involves overseeing various QMS operations and collaborating with multiple departments to maintain high standards of quality within our biotech environment.

Key Responsibilities
  • Lead Quality Systems and GxP compliance globally.
  • Oversee QMS operations including change control, deviations, CAPAs, audits, complaints, and supplier management.
  • Implement, validate, and maintain Veeva QMS.
  • Manage QMS training and completion metrics.
  • Develop an internal audit program for regulatory readiness.
  • Collaborate with Quality, Regulatory, Clinical Ops, IT, Manufacturing, and site leadership.
Requirements & Qualifications
  • B.S. in a scientific or technical field; advanced degree preferred.
  • 10+ years of experience in biotech or pharmaceutical quality with GxP.
  • Proven experience leading QMS operations, audits, and regulatory submissions.
  • Experience with Veeva or other QMS implementations.
  • Familiarity with FDA/EMA and global regulatory requirements.
  • Proven track record of building high-performing teams.

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Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: Months

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