Director Quality Control

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Summary The Director Quality Control (QC) is responsible for leading all Quality Control laboratory operations, ensuring the timely delivery of testing activities, including drug product, intermediates, stability, raw materials, and microbiology/environmental monitoring. This role ensures that all testing is executed in compliance with applicable regulatory requirements, cGMP standards, company policies, and local procedures. As a key quality leader, the Director QC oversees multiple laboratory teams with diverse functions, providing strategic direction, resource planning, performance management, and goal setting to drive operational excellence and continuous improvement. The role is accountable for ensuring the timely closure of laboratory investigations and associated CAPAs, while maintaining a strong culture of quality, compliance, and inspection readiness. The Director QC also has full ownership of the Quality Control budget, ensuring effective financial stewardship, resource allocation, and investment decisions that support business objectives and future growth. Through strong leadership and cross-functional collaboration, this role plays a pivotal part in delivering safe, effective, and high-quality products to patients. Duties/Responsibilities Directs QC laboratory to ensure timely completion of testing (e.g., drug product, intermediates, stability, raw materials) that is performed in compliance with regulatory agencies, cGMP, and other company policies and procedures. Defines departmental roles and accountabilities. Hires, integrates, and develops high-quality talent capable of delivering against the department’s goals and objectives. Establishes and communicates performance objectives for QC staff that are consistent with the business unit and Quality goals. Defines and monitors performance measures, provides developmental feedback and coaching, and creates a collaborative environment that attracts, develops, and retains the best talent.  Accountable for lifecycle management of analytical methods and technology within the QC laboratory. Directs and participates in continuous improvement efforts to drive business efficiencies (e.g., TAT improvements, COGM reductions). Directs programs which assure the proper operation and maintenance of laboratory equipment and the timely data analysis and reporting of trends. Participates 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 completion of quality records within the QMS. Accountable for completion of Annual Product Quality Review and periodic investigation trending reports. Verifies compliance with applicable BMS Policies and Procedures and ensures consistency with other site procedures and/or specifications. Responsible for managing the QC Operations budget. Fosters collaboration and communication across site and network teams.  Collaborates with managers across the QC network to harmonize best practices. Performs other tasks as required to