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Clinical QA Management Merrimack Pharmaceuticals
THIS JOB HAS EXPIRED
Merrimack Pharmaceuticals is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an initial focus on cancer. Merrimack applies Network Biology, its proprietary systems biology-based approach to biomedical research, throughout the research and development process. Merrimack currently has six targeted therapeutic oncology candidates in clinical development.The primary responsibility of this position will be development, management and continuous improvement of the GCP Quality System, leading and management of GCP audits to assure that all aspects of clinical trials conducted are being executed in compliance with applicable US FDA, ICH GCP Guidelines and other government and/ or country specific regulations, development of GCP SOPs and systems and management of GCP audits.
Job Responsibilities:
Develop, maintain and manage GCP quality systems that conform to applicable US and international regulatory requirements
Plan, prepare and manage performance of general internal and external GCP monitoring and data audits, as well as specific study-related audits
Develop proposals for solving known problems including follow-up of corrective measures
Train employees on quality management and GCP
Lead and participate in quality improvement projects
Requirements:
BS degree or higher (preferably in Biology or Chemistry)
At least 5 years? experience in clinical development, drug safety and quality management, preferably as a GCP auditor
A thorough understanding of US and international authority regulation of clinical trials
Previous leadership experience
Knowledge and experience of Good Clinical Laboratory Practices (GCLP) is a plus
Excellent written and oral communication with exceptional organization and multitasking ability
Demonstrated ability to work and achieve consensus in a team environment as well as manage projects independently
| Location: | One Kendall Square Building 700, Second Floor Cambridge, MA 02139 United States |
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THIS JOB HAS EXPIRED
Merrimack Pharmaceuticals
Investors: Physic Ventures, Unilever Technology VenturesAll Jobs: at Merrimack Pharmaceuticals
| Web Site: | www.merrimackpharma.com |
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| Headquarters: | One Kendall Square Building 700, Second Floor Cambridge, MA 02139 United States |
| Industry: | Biotechnology |
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