Senior Specialist, QA Deviation Reviewer and Approver

Bristol Myers Squibb • Summit, NJ

5d • Onsite

About The Position

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. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team. The Senior Specialist, QA Operations Deviation role will be responsible for providing quality oversight for site manufacturing operations and quality control laboratory operations at the Summit S12 Cell Therapy manufacturing facility, in accordance with Bristol Myers Squibb policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of procedures and methods; providing compliance oversight; ensure accurate and timely review of manufacturing and laboratory investigations; and identifying any trends. Shift Available: Wednesday - Saturday, Onsite Day Shift, 8AM - 6PM

Requirements

• 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.

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

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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees