Senior Director, QC Operations

Bristol-Myers Squibb - Devens, MA

Full-time - Senior

Devens, MA

Chemical Manufacturing

About the position

This role will be responsible for providing senior leadership to the Quality Control (QC) Operations organization at Bristol Myers Squibb, overseeing QC Analytical, QC Microbiology, and QC Systems activities to ensure the efficient and high-quality release of products to cell therapy patients. The individual will be a key member of the team responsible for the design, implementation, and continuous improvement of all systems and processes in support of the Devens Cell Therapy Facility's QC Laboratories. As a champion for quality principles and compliance within the Devens Cell Therapy organization, this position is crucial for maintaining the integrity and efficacy of cell therapy products. The successful candidate will demonstrate leadership and experience in QC Laboratory practices, directing the daily operations of the QC organization to support the release of cell therapy products. They will define departmental roles and accountabilities, hire, integrate, and develop high-quality talent capable of delivering against the department's goals and objectives. Establishing and communicating performance objectives for QC Operations staff that align with business unit and Quality goals will be essential. The role also involves defining and enforcing performance measures, providing developmental feedback and coaching, and creating a collaborative environment that attracts, develops, and retains top talent. Additionally, the individual will be accountable for the efficient and timely technology transfer of test methods, new products, and new technologies. They will direct programs or procedures to ensure the proper qualification, calibration, operation, and maintenance of laboratory equipment, timely data analysis, and reporting of trends, as well as the completion of written investigations in response to unusual or unexpected results or deviations. Participation in the site team for regulatory inspections and ensuring compliance with applicable BMS Policies and Procedures are also key responsibilities. The role includes managing the QC Operations budget and supporting the completion of Annual Product Quality Reviews and periodic investigation trending reports.

Responsibilities

• Demonstrate leadership and experience for QC Laboratory practices for the QC Analytical, QC Microbiology and QC Systems functions for Cell Therapy products manufactured at the Devens Cell Therapy Facility.
• Direct the daily operation of a QC organization to support the release of cell therapy products.
• Define departmental roles and accountabilities. Hire, integrate and develop high quality talent capable of delivering against the department's goals and objectives.
• Establish and communicate performance objectives for QC Operations staff that are consistent with the business unit and Quality goals.
• Define and enforce performance measures, provide developmental feedback and coaching, and create a collaborative environment that attracts, develops, and retains the best talent.
• Direct the training and scheduling of QC Operations staff to assure testing activities occur in an efficient and cGMP compliant manner.
• Accountable for the efficient and timely technology transfer of test methods, new products and new technologies.
• Direct programs or procedures which assure the proper qualification, calibration, operation and maintenance of laboratory equipment, the timely data analysis and reporting of trends, and the completion of written investigations in response to unusual or unexpected results or deviations.
• Direct QC department programs and projects (e.g., Lean Labs) related towards the goal of continuous improvement.
• Participate in the site team, which prepares for, hosts, and responds to regulatory inspections, reviews, and approvals of the facility and products.
• Accountable for on time, quality laboratory investigations and associated CAPAs within the electronic investigation management system (e.g., Infinity), as needed.
• Support completion of Annual Product Quality Review and periodic investigation trending reports.
• Verify compliance with applicable BMS Policies and Procedures and ensure consistency with other site procedures and/or specifications.
• Responsible for managing the QC Operations budget.

Requirements

• A minimum of 15 years in biopharmaceutical quality with a minimum of 6 years of increasing management responsibility of a biologics, cell therapy or drug product Quality Control laboratory or a related biopharmaceutical industry.
• Experience leading and managing a large, multi-leveled organization is essential.
• In depth knowledge of common QC procedures, techniques, and laboratory equipment/instrumentation, and the application and interpretation of GMP concepts and compendia requirements (e.g., USP, CFR).
• Proficiency in analytical assay methodologies such as molecular biology and flow cytometry assays.
• Proficiency in microbiological assays such as sterility and endotoxin.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Knowledge of cell therapy or biologics manufacturing is highly desirable.
• Extensive knowledge of US and EU cGMP regulations and guidance.
• Extensive and proven experience in FDA (or other regulatory authority) inspection preparation and management is essential.
• Knowledge of applicable business systems (e.g., SAP, LIMS, LES, Maximo, and Infinity) preferred.
• Demonstrated ability in successfully leading a large multi-level organization.

Nice-to-haves

• Knowledge of cell therapy or biologics manufacturing is highly desirable.
• Knowledge of applicable business systems (e.g., SAP, LIMS, LES, Maximo, and Infinity) preferred.

Benefits

• Competitive benefits, services, and programs that provide resources to pursue goals at work and in personal lives.