Bristol Myers Squibb · 10 hours ago
Sr. Specialist, Quality Assurance
Bothell, WA
Full-time
Onsite
Mid, Senior Level
$92K/yr - $112K/yr
3+ years expBristol Myers Squibb is a company that transforms the lives of patients through innovative work. The Sr. Specialist, Quality Assurance will provide quality oversight of Deviation related processes for clinical and commercial Cell Therapy manufacturing, collaborating cross-functionally to ensure compliance and effectiveness.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
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)
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
Qualification
Required
Bachelor's degree in STEM (Science, Technology, Engineering and Math education) and/or equivalent combination of work experience is required
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 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
Preferred
Experience in FDA/EMA regulations in the biotechnology, pharmaceutical industry; experience in protein biologics or cellular therapy field is preferred
Benefits
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.
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
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.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-02-03
Company data provided by crunchbase