The primary responsibility of this position will be management and continuous improvement of the GCP Quality System, leading and management of GCP audits to assure that all aspects of clinical trials conducted have been executed in compliance with applicable US FDA, ICH GCP Guidelines and other government and/ or country specific regulations, implementation of the internal technical quality training program, and leading and management of GMP audits.
A successful candidate will:
- Develop, maintain and manage GCP quality systems that conform to applicable US and international regulatory requirements
- Plan, prepare and perform internal and external system GCP /GMP audits as well as study-related audits
- Create audit reports and submit proposals for solving known problems including follow-up of corrective measures,
- Train employees on quality management and GCP/GMP
- Assist in development of guidelines and standards on an international level
- Lead and participate in quality improvement projects
To be successful in this position, you must demonstrate considerable knowledge in GCPs, at management level within a commercial Pharmaceutical, Biotech or Clinical Research Organization setting, including the set up and conduct of external GCP/GMP audits. The role will also require a pragmatic approach, good multitasking capabilities, attention to detail and an innovative approach.
- At least 5 years’ experience in clinical development, drug safety and quality management, preferably as a GCP auditor
- Extensive knowledge of international authority regulations and of clinical trials
- Previous leadership experience
- Knowledge of Pharmacovigilance, Good Laboratory Practices and GMP’s will be considered as an advantage.
- Ability to be productive and successful in an intense work environment
Be able to travel up to 20-30% of the time.
Indeed - 2 years ago
Synageva BioPharma is a publicly traded biopharmaceutical company with headquarters, research and development facilities in Lexington, MA,...