Sr. Specialist, Quality Assurance

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. 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: careers.bms.com/working-with-us.

Position Summary

The Sr. Specialist, Quality Assurance is an individual contributor role within the QA Investigations (QAI) team providing quality oversight of Deviation related processes for clinical and commercial Cell Therapy manufacturing at BMS Bothell.

This role:

• Collaborates cross-functionally on deviations to ensure accurate root cause analysis (RCA) and corrective and preventive actions (CAPA) have been identified.

• Ensures the deviation and associated records contains technical merit and completeness according to regulatory expectations.

• Coaches customers and team members on the deviation process and navigation within the electronic management system.

• Acts as a Subject Matter Expert in cGMP, GDocP, Data Integrity (DI)/ALCOA+ principles, risk management and right-first-time (RFT).

Duties/Responsibilities

• Conduct timely and structured reviews of deviations, lab investigations, standalone actions, proactive initiatives and their supporting records using a risk-based approach to ensure thoroughness, technical merit and compliance with regulatory requirements.

• Serve as the QA point-of-contact for deviations related to trend investigations and ineffective effectiveness check investigations, providing guidance and oversight.

• Collaborate with cross-functional investigation teams to align investigation strategies, including containment and mitigation activities, interviews, GEMBA walks, process observations and RCA.

• Support investigation teams in identifying and implementing effective CAPAs, presenting findings at review boards, and driving RFT outcomes.

• Assess and communicate the importance and impact of lot association within deviations, including impact assessments and their relation to product disposition decisions.

• Apply advanced RCA tools appropriately, demonstrating an understanding of when, where, and how to utilize each tool for effective investigations.

• Ensure accurate assignment of deviation classifications in accordance with established procedures.

• Troubleshoot and resolve issues related to deviations, escalating as necessary to ensure timely resolution.

• Influence and drive improved quality and cGMP compliance within investigation teams, with a focus on enhancing compliance and audit readiness.

• Identify and communicate inconsistencies in investigation reviews to promote calibration and alignment across the team.

• Mentor new hires and existing customers by providing training on risk-based quality decision-making, deviation review ownership, human error investigation principles, and technical writing best practices.

• Develop and deliver delta training sessions in response to procedural updates related to deviation management.

• Promote COMPASS Philosophy by actively participating in Tier 2 meetings and initiatives.

• Proactively identify gaps and opportunities within the deviation and action management processes, leading continuous improvement initiatives to enhance efficiency and effectiveness.

• Champion continuous improvement projects, including visual management, QA dashboards, Kaizen events, 5S activities, and cross-functional GEMBA walks.

• Participate as a champion for site-wide initiatives aimed at strengthening Quality Culture and improving processes, such as DI, Change Controls, and Compliance programs.

Reporting Relationship

This position reports to a QA Operations Manager.

Qualifications

Education:

Bachelor’s degree in STEM (Science, Technology, Engineering and Math education) and/or equivalent combination of work experience is required.

Experience:

• 3+ years of cGMP experience in a regulated environment, preferably in a QA or Manufacturing Science and Technology (MSAT) role.

• 2+ years working within quality systems such as Deviation Management and Document Management.

• Experience in FDA/EMA regulations in the biotechnology, pharmaceutical industry; experience in protein biologics or cellular therapy field is preferred.

• Experience with use of RCA tools and methodologies and executing deviation investigations and CAPA.

• Strong attention to detail with effective organizational, planning, and time management skills.

• Proven track record of making quality decisions based on risk impact to patient, product, and process; escalates complex quality events.

• Strong collaboration and communication skills to influence cross-functional teams and ensure alignment with quality strategy and priorities.

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.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. 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 https://careers.bms.com/life-at-bms/.
 

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

​Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)

• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

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 a supportive culture, promoting global participation 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

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

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

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [email protected]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.