Manager, Quality Assurance Investigations, Cell Therapy - Bristol Myers Squibb

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​Position Summary

The Quality Assurance Investigation Manager at the Cell Therapy Facility (CTF) in Devens, MA will be responsible for the quality review and approval of manufacturing and laboratory investigations and product complaints at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. The role will provide Quality oversight and assure the quality of manufactured products are in compliance with all applicable regulations and guidelines. 

Functional responsibilities include support and execution of root cause analysis and the determination of appropriate corrective/preventative actions as a result of investigation findings.  This individual will also be responsible for maintenance and review of SOPs, and act as a Subject Matter Expert in quality investigations and product complaints. This individual may assist in preparing for and hosting of regulatory and customer audits. The role of Manager, Quality Assurance Investigations is stationed in Devens, MA and reports to the Senior Manager, Quality Assurance Investigations for the Devens CTF.

Key Responsibilities

• Acts as QA lead to provide guidance to less experienced staff with atypical events during day-to-day operations.

• Reviews and approves discrepancy reporting, investigations and corrections and actions associated with all areas of the manufacturing process including, incoming, manufacturing, laboratory, facility, and utility systems.

• Contributes to and supports the site team which prepares for, hosts, and responds to Health Authority inspection reviews and approvals of the facility and products.

• Collaborates with Disposition Lead for timely product release of material involved in quality investigations.

• Collaborates with Compliance Lead to ensure documentation in QMS systems related to complaints and investigations follow appropriate guidelines.

• Develops process improvement strategies and supports execution of site/team continuous improvement goals and projects.

• Identifies and reports any EHS, Quality or Compliance concerns and takes immediate corrective action or escalation as required.

Qualifications and Experience

• B.S. in a life or physical science related discipline (equivalent industry experience will also be considered).

• Minimum of 6 years of pharmaceutical experience or related GMP industry.

• Must have knowledge and experience with cGMP manufacturing, quality, and compliance as well as US and global cGMP requirements.

• Demonstrates a high degree of attention to detail, with strong documentation expertise. Able to effectively multi-task and demonstrate strong organizational skills.

• Excellent verbal and written communication skills with ability to prepare written communications and communicate problems to management with clarity and accuracy.

• Demonstrated ability to develop and maintain strong business partner relationships internally and with cross-functional teams. Able to effectively work across functional groups and teams to ensure requirements are met.

• Demonstrated background in core QMS concepts, QMS architecture, QMS improvement activities.

• Demonstrated background of data-analytics for continuous improvement.

• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.

• Requires direction to complete more complex tasks; completes routine tasks with little supervision. Confident in making decisions for minor issues and routinely recognizes Quality issues and solves problems.

• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.

• Uses 5-WHY, Ishikawa Diagram and other Root Cause Analysis tools to structure and aid problem solving activities within a cross-functional team determining appropriate corrective/preventative actions as a result of investigation findings.

• Demonstrated ability to develop and maintain strong business partner relationships internally and with cross-functional teams.

• Is recognized as the Subject Matter Expert within the group for the investigation process and provides guidance to other employees in interpretation of complex data.

• Able to recognize conflict and notify management with proposed recommendations for resolution.

• Knowledge of applicable business systems including SAP, LIMS/Celabs, Maximo and Veeva Vault is desirable.

WORKING CONDITIONS:

• Must be able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, coveralls, booties, etc.).

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries toadastaffingsupport@bms.com. Visitcareers.bms.com/eeo-accessibilityto access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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