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.
Proclinical 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.
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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