Associate Director, Clinical Quality Event Management - Permanent - Cambridge, MA
Ready to engineer precision in the world of biotech? Join our client's cutting-edge team and play a vital role in developing the instrumentation that powers tomorrow's breakthroughs.
Â鶹´«Ã½ is seeking an Associate Director, Quality Event Management (Clinical Quality) to oversee and manage quality events within clinical development programs.
Primary Responsibilities:
This role focuses on ensuring compliance with regulatory requirements, driving root cause analysis, and fostering continuous improvement in clinical trial execution. You will collaborate with cross-functional teams and external partners to ensure timely resolution of issues and contribute to the success of global clinical programs.
Skills & Requirements:
- Strong expertise in clinical quality event management, including deviation handling, investigations, and CAPA management.
- Comprehensive knowledge of ICH GCP, FDA, EMA, and other global clinical trial regulations.
- Proven experience supporting regulatory inspections as an SME for GCP-related issues.
- Excellent collaboration, problem-solving, and communication skills, with the ability to influence across teams and organizations.
- Experience in oncology and/or biologics is highly desirable.
- Bachelor's degree in Life Sciences or a related field is required; an advanced degree is preferred.
The Associate Director's responsibilities will be:
- Manage the lifecycle of clinical quality events, including deviations, issues, incidents, and CAPAs, within the Quality Management System (QMS).
- Oversee investigations, ensuring consistent application of root cause analysis and adherence to ICH GCP standards.
- Monitor and report trends in quality events, escalating systemic risks as needed.
- Track and review quality events raised by contracted suppliers across functional areas, ensuring timely operational reviews and documentation collection.
- Lead the design and tracking of CAPAs to ensure effective issue resolution and prevention of recurrence.
- Collaborate with Clinical Quality Risk Management to assess broader program impacts and implement proactive risk-based approaches.
- Act as a liaison between Clinical QA and other departments, providing guidance and training on event reporting, investigation standards, and CAPA expectations.
- Serve as a subject matter expert (SME) for quality event management during inspections and audits, ensuring inspection readiness at all times.
- Contribute to inspection readiness activities across global clinical programs.
Compensation:
- $180,000 to $190,000 per annum.
If you are having difficulty in applying or if you have any questions, please contact Ingrid Aymes at i.aymes@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Â鶹´«Ã½ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Â鶹´«Ã½ is acting as an Employment Agency in relation to this vacancy.
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