Head, US Biologics Internal Mfg. Quality

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Summary:

Directs and develops the Quality operation of the Devens site ensuring compliance with Company Directives and Government Regulations; and, to lead the site's interface with worldwide regulatory authorities governing the manufacture of Biologic Drug Substance. Direct accountability to oversees the management of the Quality Operations at the Syracuse Site in addition to the Devens site.

This position ensures that all products are manufactured, tested, stored and distributed in accordance with regulatory and company standards, guides, and procedures and meet the requirements of the Domestic and International regulatory agencies. This position also oversees and audits programs to assure compliance with all principles of current Good Manufacturing Practices, Company Directives and Government Regulations to avoid costly recalls or other regulatory sanctions. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Additionally this position has direct responsibility for all compliant and timely execution of Global Market Stability testing for all commercial biologics products.

Working collaboratively with Global Product Development (both GPS-PD and R&D Q)organization, this position ensures quality and compliance oversight of the production, testing and release activities associated with the clinical manufacturing facility.

Working collaboratively with Cell Therapy Development and Operations, (both GPS-CTDO and CTQ) this position provides this organization shared quality support services for future to-be-built cell therapy operations at the Devens site.

Roles and Responsibilities

• Directs all aspects of site quality programs, systems, operations and compliance activities, including, Quality Control, Compliance, Quality Assurance, and Quality Engineering. Includes quality oversight for Commercial biologics DS manufacturing at two sites, Clinical Biologics DS mfg, Global Biologics Stability testing, and Shared quality services for future Cell Therapy operations.

• Ensures that appropriate GMP Quality Systems are in place, both through review and approval of procedures and shop floor presence, as required, and that adequate documentation exists to support and drive compliance.

• Ensures site GMP required procedures are in alignment and compliance with BMS Corporate Compliance and WWQ&C Headquarters Policies and Directives.

• Ensures adherence to the Quality unit responsibility (WWQC 2.1 current version) and provides leadership accordingly.

• Ensures that deviations from procedures and specifications are investigated, resolved and documented; that corrective/preventative actions are identified and implemented to avoid the occurrence/recurrence of deviations and that no materials are released before the completion of the investigation.

• Interfaces with Regulatory Agencies (FDA, EMA and foreign regulatory agencies) as necessary, leads site regulatory inspections and ensure compliance with the marketing authorization requirements. Interfaces directly with suppliers and customers, as well as Global Manufacturing and Supply senior management.

• Co-Chair the Tier 3 Quality Council in conjunction with the site General Manager.

• Stop manufacturing activities as appropriate.

• Assesses benefits and cost of all areas of Quality Operations and regulatory Compliance to minimize risks to the Company.

• Ensures budgets development and the preparation of periodic projections of spending against budgets; and manages and controls departmental spending.

Requirements:

• Knowledge of science generally attained through studies resulting in BS in Natural Science (Microbiology, pharmacy, biology or a related pharmaceutical science). Masters degree preferred.

• Minimum of 15 years experience in bio-pharmaceutical quality and or operations at a site level, with demonstrated leadership in pharmaceutical quality management, with at least 10 years experience in management in a Quality role.

• An in-depth knowledge of regulatory requirements for filing Biologics in the US and Europe including past productive interactions with US and European regulatory agencies for the development and manufacture of biologics

• Demonstrated proficiency in interpretation of FDA and EMA cGMP regulations for biologics

• Direct involvement in securing a BLA, or sBLA regulatory filing of a commercial facility or process

• Successful demonstration of Compliance Leadership effectiveness in quality assurance and compliance management of commercial biologics manufacturing in a global regulatory environment.

• Demonstrated success as a strong team leader who uses past supervisory experience to develop departmental staff through effective feedback and coaching.

• Proficiency in developing and managing departmental budgets.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.