Manager, Shop Floor Quality Assurance, Cell Therapy

At Bristol Myers Squibb our employees often ask Who are you working fora 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.

Shift:

Day Shift 6am - 6pm rotating schedule including holidays and weekends onsite

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.

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 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 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.

• Bachelors 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.

WORKING CONDITIONS

PHYSICAL /MENTAL DEMANDS:

• Able to work near strong magnetic fields.

• Able to gown for ISO 8 and ISO 7 rooms (medical scrubs safety shoes safety glasses gloves etc.).

We hire for skills and capabilities not just credentials if this role excites you but doesnt perfectly match your resume we encourage you to apply anyway.

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully carefully considering the nature of the role required skills work location schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors and individual team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect you may be eligible to participate in our comprehensive benefit plans including wellbeing support retirement and financial protection benefits and insurance offerings (medical dental vision life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO) which provides paid time off without a set accrual limit subject to manager approval along with 11 paid company holidays each year.

Non-exempt employees RayzeBio employees and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval) 11 paid company holidays and 3 optional holidays.

Depending on eligibility employees may also have access to additional time-off benefits including paid sick leave up to two paid volunteer days per year summer hours flexibility and leaves of absence for medical personal parental caregiver bereavement or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Years Day.

U.S.-based job seekers can explore full benefit offerings at We Work

Where you work matters because collaboration innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential site-by-design field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at People with Disabilities

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