Manager - QA Investigation and CAPA

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary (Mon - Friday 8AM to 5 PM)

• 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 of the quality of manufactured products, in compliance with all applicable regulations and BMS policies and guidelines.

Duties/Responsibilities

• Review and approve complex investigations/ CAPAs / effectiveness checks associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems.
• Author, review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the deviations program.
• Ensure the corrective/ preventive actions are robust and adequately address the root cause.
• May perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions.
• Drive implementation of effective deviation processes within representative site/function.
• Coach employees on aspects of deviations/investigations.
• Resolve investigational process or system issues.
• Ensure investigation issues are cascaded to global team and liaise with global team on routine basis.
• Champion for culture of quality within the deviation program.
• Support monitoring metrics and take relevant actions (including work prioritization) to ensure that disposition timelines and other targets are met.
• Identifies improvement opportunities and drives execution of site/team continuous improvement goals and projects.
• Support internal and external inspections as required.
• May present individual topics during audits as needed.
• Maintain compliance with assigned learning plan. Support development and delivery of training content to cross functional teams.
• Support integration of newer team members.
• Acts as Subject Matter Expert of the root cause analysis and investigations process and provides guidance/ coaching to less experienced staff with atypical events during day-to-day operations.
• May lead meetings and represent function at cross functional and network meetings.
• May be an Individual Contributor or People Manager.
• As people manager, provide direct supervision of personnel approving investigations and CAPA.

Qualifications

Specific Knowledge, Skills, Abilities:

• Ability to research, understand, interpret and apply internal policies and regulatory guidelines.
• Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheets etc. and ability to learn and work with new software applications.
• Demonstrated experience to interpret complex data & results, understand significant problems with multiple variables and critically assess and provide feedback on proposed CAPA.
• Demonstrated experience to critically review investigation reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles.
• Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy.
• 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.
• Able to independently work across functional groups and teams to ensure requirements are met.
• Ability to motivate and foster a positive team environment. • Confident in making decisions, able to anticipate Quality issues and proactively solve problems.
• Curious and ability to think critically to create innovative solutions.

Education/Experience/ Licenses/Certifications:

• Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
• 6+ years of experience in a regulated industry, preferably with 2+ year of deviation experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Demonstrated experience with electronic system and databases.
• Demonstrated proficiency in root cause analysis tools including but not limited to 5-WHY, IS/IS-NOT, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc.

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