Specialist, Quality Assurance, Investigations Approver, Cell Therapy

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

PURPOSE AND SCOPE OF POSITION:

The QSAT team is responsible for overseeing and supporting the management of deviation records through the electronic quality record management system at the Juno Manufacturing Plat (Jump) located in Bothell, WA. The QSAT Specialist Approver position is an individual contributor role responsible for providing QA oversight and approving deviation investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations.

This position will be responsible for operating cross-functionally, reviewing necessary data and information associated with the manufacturing and laboratory investigations and determine the associated corrective action to prevent the deviation from recurring. This person will be a key player in the Jump QSAT team and a champion for quality priority principles and compliance within the Jump organization.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education:

• Bachelor degree in relevant Science or Engineering discipline or equivalent experience

Experience

• 3+ years of experience in execution of deviation investigations, experience and knowledge of cGMPs and applicable FDA/EMA regulations in the biotechnology/pharmaceutical industry; experience in the cellular therapy field is preferred.
• Minimum of 2 years working within quality systems managing deviations and CAPA.
• Experience with use of complex Root Cause Analysis (RCA) tools and methodologies.
• Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.
• Background in Protein Biologics or Cell Therapy Manufacturing is required.

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.
• Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• Ability to anticipate and mitigate challenges.

DUTIES AND RESPONSIBILITIES:

Key Responsibilities

• Actively partners with Investigators to help drive on-time phase completion, including deviation closure by the original due date
• Immediately upon assignment of an investigation to an investigator, partners with the lead investigator and investigation team to help define and align on 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, partners with the investigation/CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements. Helps ensure 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
• Participates on GEMBAs to identify failure modes and seek further understanding of the deviations when needed
• Ensures HOP (Human and Organizational Performance) principles are applied to investigations
• Uses both soft-skills and technical skills to help 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
  • reviews deviations to ensure they are thorough, accurate, and complete
  • understands the overall deviation and CAPA processes including all phases of the records and proper content for each phase
  • demonstrates correct assignment of classifications and understands the requirements for each
  • understands the importance and impact of lot association within deviations and the relation to product disposition
  • ensures the necessary data to support containment activities and impact assessments have been provided
  • ensures all necessary supporting evidence is attached to the electronic deviation and that all attachments are referenced in the record
  • ensures investigations and root cause analyses are commensurate to the event being investigated
  • understands multiple RCA tools and when, where, and how they should be applied
  • reviews deviation reports for good technical writing skills
  • actively coaches and mentors investigators through the review and approval processes
• Participates on department-specific trend deviations to:
  • Assess trend details to ensure accuracy and alignment across the team
  • Participate in 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
• Maintains and routinely communicates an up-to-date dashboard of department-specific CAPA to show current status, escalate issues, provide mitigation plans, and request additional support
• understands appropriate assignment of classifications and requirements for each
• May participate on deviation governance teams, projects, and other initiatives

WORKING CONDITIONS (US Only):

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please 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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