Shift Manager, Shop Floor Quality Assurance (Day Shift, Cell Therapy, 6AM-6PM)

About the position

This is a key role on the Shop Floor Quality Assurance team. As Shift Manager for the A1 Shift (6am to 6pm), you will lead a team of 4-8 Specialists. The Shop Floor Quality Assurance team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position will oversee and partner with operational teams to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. The Manager, Shop Floor Quality Assurance, Cell Therapy is responsible for quality activities for the Cell Therapy Facility in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring operational compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues. The Manager, Shop Floor Quality Assurance role is stationed in Devens, MA and reports to the Senior Manager, Field Quality Assurance for the Devens CTF.

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 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.

Requirements

• Ability to lead an on-site quality operations teams working a 6am to 6pm shift 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 research, understand, interpret, and apply internal policies and regulatory guidelines.
• Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications.
• Advanced ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.
• Excellent written and verbal skills and advanced ability to present technical data effectively based on target audience.
• Ability to work in a fast-paced team environment and lead peers through changing priorities.
• Ability to think strategically, meet deadlines, and support work prioritization.
• Ability to negotiate and influence to craft mutually beneficial solutions.
• Ability to motivate and foster a positive team environment.
• Exhibit strong decision-making and ability to think creatively while maintaining compliance and quality.
• Pioneering mindset and ability to create innovative solutions.
• 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 records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or Quality Management Systems such as TrackWise or Veeva.
• Ability to lead change in a fast-paced environment with limited information and/or time-constraints.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is required.
• Experience with microbial controls, lean or six-sigma improvements, or as a technical/scientific process engineer in the biopharmaceutical industry preferred.
• Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
• 6+ years of relevant cGMP experience, preferably with 2+ year of QA shop floor experience.
• Ability to work within pharmaceutical cleanroom environments.

Benefits

• Competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.