Senior Specialist, MSAT Investigations

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.

Position summary

The MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality record management system at the Juno Manufacturing Plant (JuMP) located in Bothell, WA. The Deviation Investigator on the MSAT team is an individual contributor role responsible for investigating Notice of Event, Minor, Major, and Critical deviations to determine root cause, corrective actions, ensuring the written report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the manufacturing and laboratory investigations and determine the associated corrective action to prevent the deviation from reoccurring.

This person will be a key player in the JuMP MSAT team and a champion for quality priority principles and compliance within the JuMP organization.

Duties/Responsibilities

Key Responsibilities

• Actively manages deviations to achieve RFT (right first time) and on-time phase completion, including deviation closure by the original due date

• Immediately upon assignment of an investigation, partners with their investigation team (QA Reviewer/ Approver, SMEs [subject matter experts], and necessary stakeholders) on definition and alignment of the investigation plan, required data, and timing for completion. Continues to partner with investigation team throughout the investigation process to ensure agreement / alignment on root cause and CAPA

• When CAPA are needed, facilitates the investigation / CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements

• Ensures smooth transition of the defined CAPA to the owning department SME and ensures the CAPA progresses to implementation timely to ensure on-time deviation closure

• Owns and investigates department-specific trend deviations. Leads investigation team to perform deep-dive analysis of department-specific trends, including to:

  • Assess trend details to ensure accuracy and alignment across the team
  • Facilitate in-depth root cause analysis to determine additional process and system failure modes
  • Evaluate previous root causes and CAPA (in-progress or implemented) identified to lessen the trend
  • Determine if previous identified CAPA are sufficient to reduce the trend by defined targets

• Leads GEMBAs and interviews the people closest to the work to identify failure modes and seek further understanding of the deviations

• Applies HOP (Human and Organizational Performance) principles to investigations

• Uses both soft-skills and technical skills to drive the deviation and CAPA processes:

  • Demonstrates good teamwork, collaboration, and communication skills with all internal and external customers
  • Seeks to understand, demonstrates humility, and shows curiosity for learning
  • Completes deviations that are thorough, accurate, and complete
  • Understand overall deviation and CAPA processes including all phases of the records and proper content for each phase
  • Understand appropriate assignment of classifications and requirements for each
  • Understand the importance and impact of lot association within deviations and the relation to product disposition
  • Captures the necessary data to support containment activities and impact assessment
  • Attaches all necessary supporting evidence to the electronic deviation and ensures all attachments have been referenced in the record
  • Performs investigations and root cause analyses that are commensurate to the event being investigated
  • Understand multiple RCA tools and when, where, and how to apply them
  • Utilizes good technical writing skills
  • Contacts vendor as needed to complete investigations in a timely manner

Qualifications

Education:

• Minimum of Bachelor’s degree in relevant Science or Engineering discipline and/or equivalent combination of work experience is required.

Experience

• 5+ years of relevant cGMP experience. Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred.

• Minimum of 2 years working within quality systems managing deviation and CAPA records is preferred.

• Demonstrated proficiency in selection of team and effectively managing personnel issues is highly desired. Proven ability to demonstrate attention to detail, personal and team accountability where it is critical to success.

Knowledge, Skills, and Abilities

• Expertise in GMP compliance and FDA/EMA regulations.

• Demonstrate excellence in written and verbal communication.

• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.

• Ability to Anticipate and mitigate challenges

• Innovative, proactive, and resourceful; committed to quality and continuous improvement.

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

Compensation Overview: Bothell - WA - US: $90,660 - $109,860

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 Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How 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 https://careers.bms.com/ways-of-working.

Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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R1607303 : Senior Specialist, MSAT Investigations