Sr. Director, Aseptic Operational Support

Role: Senior Director of Aseptic Operational Support at Bristol Myers Squibb, providing enterprise leadership in sterility assurance, contamination control, and aseptic processing across global manufacturing sites. Responsibilities include defining and implementing policies, standards, and strategies for microbial control; overseeing environmental monitoring programs; managing high-risk contamination events; and ensuring compliance with regulatory requirements (FDA, EU GMP, ICH). The role also involves driving cross-site harmonization, knowledge sharing, and continuous improvement initiatives, as well as providing technical authority on aseptic sciences and representing the company during regulatory inspections. Qualifications: Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or related field; 15+ years in microbiology, sterility assurance, or contamination control with 8–10 years in senior leadership roles overseeing enterprise quality or compliance; extensive experience with manufacturing modalities such as small molecules, biologics, cell, or gene therapies; deep knowledge of global regulatory frameworks and experience supporting regulatory inspections. Skills include enterprise thinking, technical expertise in aseptic sciences, executive communication, change leadership, data fluency, and cross-functional collaboration. Preferred: M.S. or Ph.D. in Microbiology or related discipline. The position is based in Devens MA, with work model details not specified but likely hybrid or onsite given the scope. Travel requirements are not explicitly mentioned.