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QA Associate Director - Analytical Laboratory Lead - New Brunswick

Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: September 4, 2019

Job Description:

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. Summary: • Lead team in providing Quality oversight for testing of clinical supplies (investigational products) to assure quality and compliance with Good Manufacturing Practices (GMP) and other applicable regulations and internal procedures. • Coordinates the assignment of tasks to be performed by the assigned managers/Associates/Specialists. • Assure the quality of manufactured products complies with all applicable regulations and guidelines. Responsibilities: Direct and oversee site analytical testing - quality control compliance to regulations and internal procedures. Develop and manage responsibilities for the quality oversight of Analytical Laboratory Control QC/QA including but not limited to the following: change controls, quality agreements, method development, investigations, clinical testing specifications, and raw material release activities. Build and foster strong relationships and partnerships with stakeholders and support groups to meet the demands of a changing business culture and environment. Participate in development of quality policies, global SOPs, and implementation of site SOPs to ensure site compliance with appropriate procedures. Brings to the attention of the Quality Operations Management, any information relating to the impact of legislation on the functions of the department, system deviations, etc. Provides instruction and guidance on quality issues and serves as a resource for the site. Supports site operations during regulatory agency and third party inspections. Professional experience and qualifications: Knowledge of science generally attained through studies resulting in B.S. or M.S. in chemistry, pharmacy or biology or a related pharmaceutical science A Ph.D. in a related science with 8-10 years of relevant experience within the pharmaceutical or healthcare industry, or a M.S. with 11-13 years experience, or a B.S. with 13-15 years experience; including 5+ years experience in a regulated function. Knowledge of biopharmaceutical analytical methods. Technical expertise in resolution of deviations and development of effective CAPA. Experience in Quality Management at development and/or commercial stage of pharmaceutical operations. Experience within a QA/QC environment is required Broad experience in the manufacturing of sterile and non-sterile products In-depth knowledge of GMP regulations Strong problem solving, interpersonal and organizational skills Strong collaborative and influencing skills Effective written and verbal communication Computer literacy: Microsoft Office and SAP environment Trackwise®, PDLIMs, and other systems as required Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Keywords: Bristol-Myers Squibb Company, New Brunswick , QA Associate Director - Analytical Laboratory Lead - New Brunswick, Other , New Brunswick, New Jersey

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