Senior Manager, QA Engineering; Equipment​/Lab Methods​/Utilities​/Facilities

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.

This is work that transforms the lives of patients, and the careers of those who do it.

The Senior Manager is responsible for providing quality oversight for Site Validation activities and Quality Control Laboratory method and equipment validation in accordance with BMS policies, standards, procedures, and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of validation and qualification documents for all equipment and facility activities, support data integrity initiatives for the site.

Note:

This Senior Manager, QA Engineering (Equipment/Lab Methods/Utilities/Facilities) role may apply to individual contributor or people manager. When fulfilling the people manager role, the Senior Manager, QA Engineering (Equipment/Lab Methods/Utilities/Facilities) is responsible for leading the team, with distinct roles and responsibilities, in maintaining alignment between business process owners, end users, and other cross functional groups/areas.

Supports all activities for the QA Engineering group. Supports the Qualification and Validation activities in relation to QC and manufacturing equipment, utility, and facility design. Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports, and procedures. Ensures compliance with the site validation master plan, assists with facility start-up operations and product transfers supporting the Qualification and Validation teams. Ensures site is compliant with global and regulatory data governance and data integrity requirements.

Establishes and maintains procedures to ensure Data Integrity is maintained and procedures/processes are compliant. Works with laboratory management to ensure laboratory activities comply with global regulatory requirements. Ensures the site stability program meets global and regulatory requirements. Ensures method qualifications, method transfers, and analyst trainings meet company and regulatory requirements. Manage QA Engineering team and assures job objectives are met on a timely basis.

This position will report to Associate Director, QA Operations
- Quality Engineering.

Qualifications Specific Knowledge, Skills, Abilities:
Must have GMP, Quality, and in-depth risk management knowledge. Experience in design of user requirement specifications, IQ/OQ/PQ protocols, user acceptance testing and other equipment/utility/facility qualification documentation. Must be fluent in standard Microsoft Office software; experience in Computer Maintenance Management System (e.g., Maximo) and quality systems software (e.g., BMSDocs Electronic Document Management System, Infinity/Valgenesis). Must be able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.

Must manage development of technical or scientific initiatives and activities by interdisciplinary teams. Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles. Must be able to recognize…