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

̽»¨ºÏ¼¯ 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.

If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

̽»¨ºÏ¼¯ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ̽»¨ºÏ¼¯ is acting as an Employment Agency in relation to this vacancy.