Manager - QA Investigation and CAPA

Bristol Myers Squibb • Summit, NJ

3d • $93,910 - $113,794

About The Position

The Manager, QA Investigations is responsible for quality oversight and approval of deviation assessments, investigations, and associated action and effectiveness check records at the Summit Cell Therapy Facility. The role provides quality oversight and assurance for manufactured products in compliance with applicable regulations and BMS policies and guidelines. The position may be an individual contributor or a people manager; people managers directly supervise personnel who approve investigations and CAPAs.

Requirements

• At least 6 years of experience in a regulated industry, preferably including at least 2 years of deviation experience.
• Ability to research, understand, interpret, and apply internal policies and regulatory guidelines.
• Proficient computer skills, including knowledge of digital tools such as MS Office and Smartsheets, and ability to learn and use new software applications.
• Experience interpreting complex data and results, understanding significant problems with multiple variables, and critically assessing and providing feedback on proposed CAPAs.
• Experience critically reviewing investigation reports, interpreting results, and assessing and challenging technical conclusions consistent with Quality risk management principles.
• Excellent verbal communication and technical writing skills, including the ability to prepare written communications and present technical data clearly and accurately to management.
• Ability to work in a fast-paced team environment and lead peers through changing priorities.
• Ability to think strategically, meet deadlines, and support work prioritization.
• Ability to work independently across functional groups and teams to ensure requirements are met.
• Ability to motivate others and foster a positive team environment.
• Confidence in making decisions, anticipating Quality issues, and proactively solving problems.
• Curiosity and critical-thinking ability to create innovative solutions.
• Demonstrated experience with electronic systems and databases.
• Proficiency in root cause analysis tools, including 5-WHY, IS/IS-NOT, Human Error Prevention, Ishikawa Diagram (Fishbone Analysis), and Process Flow Diagram.

Nice To Haves

• Bachelor's degree in a STEM field preferred.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing preferred.
• A high school diploma or associate degree with an equivalent combination of education and work experience may be considered.

Responsibilities

• Review and approve complex investigations, CAPAs, and effectiveness checks associated with incoming materials, manufacturing, laboratory, facility, and utility systems.
• Author, review, and approve technical reports, including risk assessments and deviation system monitoring reports, to support the deviations program.
• Ensure corrective and preventive actions are robust and adequately address root causes.
• Perform routine reporting and analysis of metrics as needed to support timely closure of quality events and actions.
• Drive implementation of effective deviation processes within the representative site or function.
• Coach employees on deviations and investigations.
• Resolve investigational process or system issues.
• Cascade investigation issues to the global team and liaise with that team routinely.
• Champion a culture of quality within the deviation program.
• Monitor metrics and take relevant actions, including prioritizing work, to meet disposition timelines and other targets.
• Identify improvement opportunities and drive execution of site and team continuous-improvement goals and projects.
• Support internal and external inspections and present individual topics during audits as needed.
• Maintain compliance with the assigned learning plan and support development and delivery of training to cross-functional teams.
• Support integration of newer team members.
• Serve as a subject matter expert in root cause analysis and investigations, providing guidance and coaching to less experienced staff on atypical events during day-to-day operations.
• Lead meetings and represent the function at cross-functional and network meetings as needed.
• As a people manager, directly supervise personnel approving investigations and CAPAs.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
• Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• For specified employee groups, 160 hours of paid vacation annually for new hires, subject to manager approval.
• 11 paid company holidays each year.
• Three optional holidays for specified employee groups.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for additional discretionary cash incentives and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED