Bristol-Myers Squibb - Devens, MA
posted 2 months ago
Full-time - Senior
Hybrid - Devens, MA
Chemical Manufacturing
About the position
The Senior Manager Nights, Quality Assurance Shop Floor (QASF) at Bristol Myers Squibb plays a crucial role in ensuring the highest quality standards in cGMP processes. This position involves leading and mentoring night-shift managers and their teams, driving excellence in quality assurance, and fostering a culture of quality within the organization. The role offers a unique blend of technical challenges and leadership opportunities, making it ideal for individuals with a strong desire to learn and grow in a dynamic environment.
Responsibilities
- Lead and mentor night-shift managers and their teams, ensuring effective communication and high performance.
- Uphold and improve quality standards through cross-functional collaboration and influence.
- Develop and implement training programs to enhance the technical acumen and effectiveness of the night-shift teams.
- Utilize analytical thinking to solve complex quality issues and drive continuous improvement.
- Provide leadership to ensure routine on-the-floor Quality oversight and collaborative triages of unexpected events.
- Respond to complex/critical issues and build consensus with subject-matter experts for product impact.
- Serve as a subject matter expert supporting others in navigating the BMS quality management system.
- Provide direction and timely guidance to QA shift-managers regarding cGMP events.
- Accountable for the performance/delivery of the QA field quality organization.
- Champion a culture that embraces psychological and physical safety of employees.
- Proactively identify and address quality risks and critical issues, driving mitigations with cross-functional partners.
- Lead and/or represent QA in leadership, staff, and tier meetings, governance forums, or project teams.
- Act as a QA subject matter expert during audits and inspections.
- Review and interpret technical conclusions of records/investigations and provide feedback.
- Independently approve deviation records within the quality management system.
- Regularly coach and mentor operators and Field QA specialists on the manufacturing floor.
- Interview, hire, coach, motivate, and develop exceptional staff.
Requirements
- Master's degree in STEM or an MBA preferred; Bachelor's/Associates degree with equivalent experience considered.
- 8+ years of relevant cGMP experience, preferably with 4+ years of manufacturing site experience.
- Ability to lead on-site quality operations teams working 12-hour shifts on a rotating schedule.
- Demonstrated experience with quality management systems for handling records such as change control and CAPA management.
- Experience working in aseptic/sterile environments and/or in quality control operations focused on microbial controls is preferred.
- Ability to think strategically and prioritize work according to business needs.
- Strong decision-making ability and analytical thinking while maintaining compliance and quality.
Nice-to-haves
- Experience with microbial controls, lean or six-sigma improvements, or as a technical/scientific process engineer in the biopharmaceutical industry.
- Demonstrated experience working with GxP electronic systems such as MES, ERP, or Quality Management Systems.
Benefits
- Competitive salary and benefits package
- Opportunities for professional development
- Flexible work environment
- Health and wellness programs
- Employee assistance programs
