Manager, Investigation Program Quality Systems

Descripción del Empleo:
Incumbent support the site’s Investigation and CAPA Programs to ensure it meets regulatory and industry expectations and has appropriate understanding of risk. Support the communication of the program’s vision and progresses its sustainability by facilitating governance for the program to deliver per expectations by driving for continuous improvement and designing and developing countermeasures to address deficiencies at a program level. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
Requisitos:
BS or master degree in Natural Science (Chemistry, Pharmacy, Biology, Engineering or a related pharmaceutical science). Master’s Degree in Science preferred.
• Eight (8) years of progressive managerial experience within the quality assurance function of the pharmaceutical/health care industry and regulatory agencies, with 5 years of experience in aseptic filling and finishing areas for liquid and lyophilized products and medical devices. Ability to develop and apply BMS’s operating philosophy and to operate within Company policies and procedures within Manufacturing, Quality and Compliance, Marketing and Regulatory areas. Proficient in cGMP’s and FDA regulations and requirements. Experience in containment technologies. Understanding of the business and marketing aspects of pharmaceutical operations in a highly regulated industry is extremely important