• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: GXP Quality Dir.

Job Number: 34383

Location:

Job Description

Looking to hire a Director of GXP Quality to oversee quality assurance activities. Responsibilities include ensuring compliance with QMS management, regulatory standards, and supporting GLP studies. This role reports to the Head of Development Operations.

Responsibilities

  • Offer support to teams.
  • Manage routine and non-routine quality audits.
  • Lead controlled document committee.
  • Develop audit plans and schedules.
  • Ensure prompt resolution of quality issues.
  • Liaison to vendors' and counterparts.
  • Assist in regulatory inspection preparation.
  • Review trial documents and GLP reports.
  • Fulfill extra duties as required.

Required Skills

  • Bachelor’s Degree in a scientific field; advanced degree preferred.
  • Minimum 8 years in pharmaceuticals, with 5 in GCP QA.
  • Strong grasp of clinical standards.
  • Experience with US and international trials.
  • Ability to travel 25% domestically and internationally.
  • Strong verbal and written communication, including document review.
  • Independent with good organizational skills.
  • Collaborative problem-solving abilities.

 

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