Senior Manager, Quality Assurance Shop Floor 2nd Shift

Job description

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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. Read more: careers.bms.com/working-with-us. Position: Senior Manager, Quality Assurance Shop Floor 2nd Shift Location: Devens, MA Position Summary The Senior Manager, Quality Assurance Shop Floor (QASF) 2nd Shift is a key people leader. The incumbent manages front line managers, and their teams, and will play a pivotal role in ensuring the highest quality standards in our cGMP Cell Therapy processes. The QASF organization is responsible for quality oversight of shop-floor activities at the Devens Cell Therapy Facility (CTF) including the manufacturing, release testing, and packaging of autologous drug product. The incumbent will be at the forefront of our night shift operations, fostering a culture of quality. They will be be responsible for the hiring, training, and leadership of two night-shift managers and their respective teams, ensuring they are equipped to meet and exceed quality standards. They work in a dynamic setting needing to influence cross-functionally, problem solve and be the senior Quality Assurance leader representing the night shifts. This role combines quality, compliance, and leadership, ideal for someone eager to coach and support a growing team. Work Schedule: Standard Hours: 3:00 PM start, Monday to Friday, on-site at Devens, MA Shift Leadership: Oversee two night-shift managers and respective teams working an alternate 3-2-2 Panama schedule from 6:00 PM to 6:00 AM, 7 days a week. Key Responsibilities: Lead and mentor night-shift managers and their teams, ensuring effective communication and quality performance. Uphold and improve quality standards through cross-functional collaboration and influence. Develop and implement continuous improvement efforts to enhance the quality and compliance acumen and effectiveness of the night-shift teams. What We’re Looking For: A high degree of regulatory, quality and compliance acumen and a strong desire to learn. Proven leadership skills with the ability to mentor and develop staff. Excellent communication and analytical thinking abilities. A proactive approach to cross-functional collaboration and quality improvement. The Senior Manager will lead their teams to ensure patient safety in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs). This position reports to the Associate Director, Quality Assurance Shop Floor and is a part of the QASF Leadership Team. Key Responsibilities Provide leadership to ensure routine on-the-floor Quality oversight and to ensure collaborative triages of unexpected events within the Manufacturing, Quality Labs, and Supply Chain operational areas and systems. Have a comprehensive understanding of Cell Therapy processes to enable real-time decision-making. Advanced ability to synthesis information from multiple sources, interpret problems and effectively communicate to cross-functional management in a clear, brief, and accurate manner. Respond to complex/critical issues and build a consensus of understanding with subject-matter experts for product impact and justification to continue manufacturing. Serve as a subject matter expert supporting others to navigate the BMS quality management system including but not limited to deviation and CAPA action management, interim production controls, disposition decisions, and batch record management. Provide direction and timely guidance to QA shift-managers regarding the handling and resolution of cGMP events which may be a part of deviations, batch record exceptions, and other quality operational issues. Accountable for the performance/delivery of the QA field quality organization, including oversight of the “QA on-the-floor” systems and programs that enable the highest quality and the quickest delivery of QA cGMP tasks. Develop and implement standard-work for team-members that balances on-floor support for non-routine events, routine quality assurance work, and stretch/development project-work. Champion a culture that embraces psychological and physical safety of employees in the work environment. Champion a culture of teamwork, communication, and continuous improvement focused on defining problem statements, driving initial investigative efforts, and actioning solutions to reduce recurrence. Proactively identify and address quality risks and critical issues, drive mitigations with the aid of Field Quality Staff and cross-functional partners and escalate to senior management as needed. Lead and/or represent QA in leadership, staff and tier meetings, governance forums or on project teams. Act as a QA subject matter expert on behalf of the facility during audits and inspections. Provide timely QASF support to site compliance activities such as Change Control impact assessments, deviation impact assessments, and development of corresponding CAPAs. Lead walkthroughs with peers or QA team-members to identify and remediate operational or quality issues. Review and interpret the technical conclusions of a record/investigation and provide constructive feedback. Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge Regularly spend time coaching and mentoring operators and Field QA specialists while on the manufacturing floor. Interview, hire, coach, motivate, and develop exceptional staff. Set performance objectives and development plans. Monitor performance progress and conduct performance reviews for all direct reports. Qualifications & Experience Ability to lead on-site quality operations teams working 12-hour shifts on a rotating 2-3-2 Panama schedule. Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management. Experience working in aseptic/sterile environments and/or in quality control operations focused on microbial controls and contamination mitigation strategies is preferred. Ability to think strategically, with an enterprise-mindset, establish deadlines and prioritize work according to the needs of the business and within budget. Ability to research, understand, interpret, and apply internal policies, cGMP, and quality principles. Establishment of strategic goals, departmental objectives, and motivating team to achieve operational tasks. Exhibits strong decision-making ability and analytical thinking while maintaining compliance and quality. Proactively finds solutions to quality and operational problems by creative thinking and innovative solutions. Proven ability to negotiate mutually beneficial solutions and resolve differing perspectives among stakeholders. Ability to understand complex problems with multiple datum/variables and articulate practical solutions. Excellent technical writing/verbal skills. Ability to effectively present technical data based on target audience. Demonstrated experience working with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch recor