Senior Director, QC Operations

Bristol-Myers Squibb - Devens, MA

Full-time - Senior

Devens, MA

Chemical Manufacturing

About the position

The Senior Director of QC Operations at Bristol Myers Squibb will provide senior leadership to the Quality Control (QC) Operations organization, overseeing QC Analytical, QC Microbiology, and QC Systems activities. This role is crucial for ensuring the efficient and high-quality release of cell therapy products to patients. The individual will be a key member of the CTF Quality Leadership Team, championing quality principles and compliance within the Devens Cell Therapy organization. The position is stationed in Devens, MA, and reports to the Executive Director of Quality for the Devens Cell Therapy Facility. In this role, the Senior Director 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. Responsibilities include defining departmental roles and accountabilities, hiring and developing high-quality talent, and establishing performance objectives for QC Operations staff that align with business unit and Quality goals. The Senior Director will also be responsible for the training and scheduling of QC Operations staff to ensure compliance with cGMP standards. The role includes accountability for the efficient and timely technology transfer of test methods, new products, and new technologies. The Senior Director will direct programs to ensure proper qualification, calibration, operation, and maintenance of laboratory equipment, timely data analysis, and completion of written investigations in response to deviations. Additionally, the individual will participate in site teams preparing for regulatory inspections and will be accountable for on-time, quality laboratory investigations and associated CAPAs within the electronic investigation management system. This position requires a strong focus on continuous improvement, directing QC department programs and projects, and ensuring compliance with applicable BMS Policies and Procedures. The Senior Director will also manage the QC Operations budget, ensuring that resources are allocated effectively to meet departmental goals.

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 for employees to pursue their goals at work and in their personal lives.