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