Senior Specialist, Quality Approver, Cell Therapy

  • Bristol Myers Squibb
  • Bothell, WA, USA
  • Nov 21, 2023
QA-Quality Control

Job Description

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more:

Position Summary:

The Quality Assurance Approvers (QAA) team is responsible for supporting the management of deviation and CAPA records through the electronic quality record management system at the Bristol Myers Squibb located in Bothell, WA.

The QAA Sr. Specialist role is an individual contributor role responsible for the review and approval of events classified as Minor, Major, and Critical deviations.  Management of deviation and CAPA records will include: 

  • cross-functional collaboration to ensure the proper root cause and corrective actions have been identified 
  • ensuring the written report contains the technical merit and completeness according to regulatory expectations 
  • coaching customers on navigation within the deviation management electronic system 

Additionally, this role will be involved in trend investigations, continuous improvement, and executing training schedule for new hires.

Knowledge, Skills and Abilities:


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


  • 5+ years of relevant cGMP experience.
  • Minimum of 3 years working within quality systems.
  • Experience executing deviation investigations and CAPA.
  • Experience in FDA/EMA regulations in the biotechnology / pharmaceutical industry; experience in protein biologics or cellular therapy field is preferred.
  • Experience in a Quality Assurance or technical Manufacturing Science and Technology role within a GMP manufacturing organization.
  • Experience with using complex Root Cause Analysis (RCA) tools and methodologies.
  • Experience with using Quality Risk Management principles.

Roles and Responsibilies:

  • Review multiple forms of root cause analyses, technical writing, and lead without direct influence
  • Understands the overall deviation and CAPA management process including all phases of the records and proper content for each phase
  • Ensures partnering with cross-functional investigation team (Investigator, SMEs, and necessary stakeholders) to align on overall direction, strategy, investigation content and root cause
  • Work with team members to identify roadblocks and escalate for resolution/recommendation
  • Ensures investigation team are meeting requirements outlined in all procedures, work instructions, standard work practices, and business processes
  • Understands the importance and impact of lot association within deviations and the relation to product disposition
  • Ensures the deviation captures the necessary data to support containment, mitigation activities and impact assessment
  • Understands multiple RCA tools and when, where, and how to apply each tool
  • Ensures investigations and root cause analyses are commensurate with risk to the event being investigated
  • Understands appropriate assignment of deviation classifications
  • Assist the investigation team in identifying solutions and driving RFT (right first time)
  • When CAPAs are needed, partners with the investigation / CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements
  • Ensures deviations are thorough, accurate, and complete
  • Assists with on-time completion of deviation and CAPA
  • Identifies gaps and opportunities in the deviation and CAPA processes and drives continuous improvement initiatives
  • Coaches and mentors direct and indirect team members on investigations, root cause analyses, technical writing, GEMBAs, Human and Organization Performance (HOP) principles, and Right to Operate (RTO)
  • Collaborates with cross-functional investigation teams on department-specific trend deviations. Provides guidance to the investigation team for performing a deep-dive analysis of department-specific trends, to include:
  • Assessing trend details to ensure accuracy and alignment across the team
  • Facilitating in-depth root cause analysis to determine additional process and system failure modes
  • Evaluating previous root causes and CAPA (in-progress or implemented) identified to lessen the trend
  • Determining if previous identified CAPA are sufficient to reduce the trend by defined targets
  • Maintain a communication plan with the direct Manager on updates regarding the status of deviations and CAPAs
  • Partners with the QAA leadership to understand inconsistencies in investigations and/or reviews/approvals to ensure ongoing continuous improvement and calibration amongst the team
  • Partners with other QAA qualified staff to develop and execute training plan for new QAA team members
  • May participate on deviation governance teams, projects, and other initiatives
  • Demonstrates good teamwork, collaboration, and communication skills with all internal and external customers
  • Seeks to understand, demonstrates humility, and shows curiosity for learning

The starting compensation for this job is a range from $75,000 to $95,000, plus incentive cash and stock opportunities (based on eligibility). 

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. 
Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, 
pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). 
Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like 
tuition reimbursement and a recognition program.


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.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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

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 Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Partner ID