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Director / Senior Director, Head of Quality Assurance

Proclinical
San Diego, CA Full Time
POSTED ON 2/13/2025
AVAILABLE BEFORE 5/6/2025

Director / Senior Director, Head of Quality Assurance (GCP / Clinical Quality) - San Diego, CA

Proclinical has been retained by an innovative, fast-growing specialist CRO based in San Diego for the appointment of a critical Director or Senior Director level candidate to head up Quality Assurance. This client and position is based in San Diego, California but they can support a relocation for the right candidate.

Primary Responsibilities :

As the Head of Quality for this specialist CRO this person will lead a small team that oversees the whole Quality function. With particular focus on managing and enhancing compliance and quality systems across the drug development process. The successful candidate will play a crucial role in ensuring adherence to regulatory requirements and company standards.

Skills & Requirements :

  • Bachelor's degree in a relevant field.
  • Strong knowledge of GCP (Good Clinical Practice; FDA and ICH) and 21CFR Part 11.
  • Understanding of US / ICH regulatory requirements and compliance guidelines.
  • Ability to proactively resolve quality issues diplomatically and constructively.
  • Experience with GLP and GMP is desirable.
  • Excellent written and oral communication skills.
  • Ability to manage multiple tasks with attention to detail.
  • Prior experience in people management.

The Director / Senior Director GCP QA's responsibilities will be :

  • Develop and manage compliance and quality systems, including policies and SOPs.
  • Oversee SOP training programs and maintain training records.
  • Conduct internal and external audits to ensure regulatory compliance.
  • Lead QA-Clinical Operations meetings and provide updates to senior management.
  • Provide QA input on projects, review clinical study reports, and manage quality-related activities.
  • Manage regulatory inspections and client audits, addressing observations until resolution.
  • Support non-clinical and CMC development activities.
  • Oversee and manage QA department personnel.
  • Assist with regulatory submissions and business development activities.
  • Compensation :

  • 190,000 to $200,000 per annum.
  • Salary : $190,000 - $220,000

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