Associate Director, GCP QA - Florham Park

Only for registered members Florham Park, United States

1 month ago

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$160,000 - $190,000 (USD)

Job summary

The Associate Director provides senior-level quality oversight for Shionogi's clinical development activities ensuring compliance with global regulatory requirements. They serve as QA representative to assigned study teams evaluate processes practices documentation and study plans to identify compliance risks drive resolution of quality issues. The role also contributes to maintaining Pharmacovigilance System Master File (PSMF).

Responsibilities

  • Provide quality oversight of clinical trial operations PV ensure GCP/GVP regulatory compliance ICH FDA EMA MHRA PMDA local authorities.
  • Serve as QA Representative assigned clinical study teams advisory PV.
  • Evaluate clinical trial documentation processes study plans ensure alignment Shionogi expectations regulatory requirements.

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