Bristol Myers Squibb · 1 week ago
Senior Specialist, QA Deviation Reviewer and Approver
Summit, NJ
Full-time
Onsite
Mid, Senior Level
$84K/yr - $102K/yr
5+ years expBristol Myers Squibb is a company focused on transforming patients' lives through science, particularly in the field of cell therapy. The Senior Specialist, QA Deviation Reviewer and Approver will provide quality oversight for manufacturing operations and quality control laboratory operations, ensuring compliance with policies and standards while managing deviation investigations and corrective actions.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Supports all activities for the Quality Operations Investigations group
Review and approve Site operational investigation, Complaint and Trend Investigations
Review and approve Supplemental actions
Review and approve Impact assessments or Product Quality Evaluation Approval
Review and Approve Corrective and Preventive Actions (CAPA Plan, Action approval, Effectiveness Check (EC) Plan, EC execution Approval)
Participates in Audit and inspection including inspection readiness activities
Attend and participate at Investigation and CAPA Review Board (IRB/CRB)
Review and approve Investigation Protocol/Plan and Summary report
Review and approve interim controls (Mitigation protocols) for continued production
Review and approve Proactive Initiatives
Review and approve Standalone actions
Contribute to deviation management procedure improvement
Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations
Must be skilled in planning and organizing, decision-making, and building relationships
Able to effectively work in a dynamic / fast-paced environment
Meets and exceeds all safety expectations and adheres to all BMS behaviors and values
Qualification
Required
Must have advanced knowledge on the review of deviation investigation and CAPA
Must have advanced knowledge on how to perform Root Cause Investigation
Must have advanced knowledge and experience with cGMP manufacturing, Quality, and Compliance
Must partner with Investigation team for efficiently and timely completion of deviations
Proactively seeks to resolve deviations/investigation roadblocks impeding deviation and/or CAPA record on-time closure and release to patients
Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles
Must be able to effectively prepare communications to management with clarity and a high level of accuracy
Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, conflict management, coaching other and analytical thinking
Must possess an independent mindset and tenacity
Requires moderate direction to complete complex tasks; completes routine tasks with little or no supervision. Work is self-directed
Confident in making decisions for minor issues
Is recognized as Subject Matter Expert that facilitates coaching of new hires
Contributes to goals within the work group
Knowledge of aseptic manufacturing processes
Works within cross functional teams to resolve deviations/investigation roadblocks impeding deviation and/or CAPA record on-time closure and release to patients
Excellent verbal and written communication skills
Bachelor of Science in Physical Sciences, Engineering, related discipline. An equivalent combination of higher education and demonstrated experience will be considered
Minimum of 5 years' experience in related cGMP environment: Cell Therapy, Pharmaceutical, Biologics, Medical Device operations
Minimum of 4 years in QA/QC
At least 1-2 years investigation experience
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
Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work.
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
2026-01-09
2026-01-08
Company data provided by crunchbase