Quality Director

Responsibilities

• Direct all aspects of site quality programs, systems, operations, and compliance activities, including Quality Assurance, Compliance, and Quality Assurance Validation.
• Ensure appropriate GMP Quality Systems are in place and maintain a state of health authority inspection readiness.
• Ensure site GMP required procedures align with the BMS Quality Management System (QMS) Process Framework.
• Oversee the investigation, resolution, and documentation of deviations from procedures and specifications.
• Interface with Regulatory Agencies, lead site regulatory inspections, and ensure compliance with marketing authorization requirements.
• Participate in product recall and health authority notification processes.
• Manage departmental spending, including budget development and periodic projections.
• Provide quality and compliance oversight for regulatory submissions and new product introductions.
• Serve as a key strategic member of the Site Leadership Team, representing Global Quality within the Biologics Operating Unit.

Requirements

• Degree in science, engineering, or a related discipline.
• Minimum of 15 years of experience in a Quality Leadership role within the pharmaceutical industry.
• In-depth knowledge of Japanese regulatory and GMP requirements.
• Fluency in the English language (verbal, written, and presentation skills).
• Proven ability to lead teams, coach staff, and work effectively within complex matrix organizations.

About the Company

Bristol Myers Squibb is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. We foster a culture of passion, innovation, and integrity, providing opportunities for high-achieving teams to transform lives through science.