Associate Director, Quality Assurance
2 months ago
Proclinical is seeking a dedicated and dynamic Quality Assurance professional for the role of Associate Director. This role is a unique opportunity to contribute to the growth and evolution of our Quality function. The successful candidate will collaborate with Clinical Development colleagues, oversee external contract vendors, and contribute to the development of the Quality Management System. This role is perfect for someone who enjoys a diverse range of responsibilities and thrives in a collaborative and energetic environment.
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Responsibilities:
- Serve as the primary Quality contact for external clinical and patient safety vendors.
- Contribute to the development of the GCP/GCLP/GVP Quality Management Systems.
- Review and approve GCP/GCLP/GVP related documents such as study protocols, clinical study reports, etc.
- Create and execute risk-based clinical trial audit plans.
- Develop and implement a GCP/GCLP/GVP inspection readiness strategy.
- Conduct internal audits and provide audit metrics.
- Develop and execute Quality Agreements with applicable vendors.
- Manage quality investigations associated with GCP/GCLP/GVP operations.
- Provide Quality Assurance expertise, leadership, and guidance to external CROs.
- Review applicable GCP/GCLP/GVP documentation and regulatory submissions.
Key Skills and Requirements:
- Bachelor's degree in a scientific field.
- Extensive experience in Quality Assurance/GCP/GCLP/GVP Operations within the pharmaceutical or biotech industry.
- In-depth knowledge of GCP/GCLP/GVP and QA principles, practices, and standards.
- Thorough understanding of FDA, MHRA, EMA and ICH quality regulations.
- Excellent communication skills and willingness to travel to GCP/GCLP/GVP sites, both domestic and international.
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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