Senior Specialist, Quality Assurance Investigations

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 rich in diversity. 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.

PURPOSE AND SCOPE OF POSITION

• 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 associated with the Investigation Program and Quality Operations.
• The Quality Assurance Investigation Senior Specialist is responsible for providing support for the review and approval of 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 ensure the quality of manufactured products are in compliance with all applicable regulations and guidelines.

REQUIRED COMPETENCIES Knowledge, Skills, And Abilities

• Must have knowledge and experience with cGMP manufacturing, quality, and compliance as well as US and global cGMP requirements.
• Able to recognize conflict and escalate to management.
• Demonstrated background in core QMS concepts and QMS improvement activities.
• Demonstrates a high degree of attention to detail, with strong documentation expertise. Able to effectively multi-task and demonstrate strong organizational skills.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Participates as requested in the response team for audits and inspections by world health authorities.
• Excellent verbal and written communication skills with ability to prepare written communications and communicate problems to management with clarity and accuracy.
• 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. Able to effectively work across functional groups and teams to ensure requirements are met.
• Represents QA in cross functional meetings.
• Working knowledge of applicable business systems including SAP, LIMS/Celabs, Maximo and/or Veeva Vault.
• 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.

Duties And Responsibilities

• Represents QA in cross functional meetings.
• Identifies and reports any EHS, Quality or Compliance concerns and takes immediate corrective action or escalation as required
• 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
• Provides quality support and oversight for Manufacturing Science and Technology and Validation protocols and reports.
• Collaborates with Compliance Lead to ensure documentation in QMS systems related to complaints and investigations follow appropriate guidelines.
• Drives process improvement strategies and supports execution of site/team continuous improvement goals and projects.
• Reviews and approves investigations, corrections and actions associated with all areas of the manufacturing process including incoming, manufacturing, facility and utility systems.
• Provides training on QA owned procedures.
• Participates in the startup of the Devens Cell Therapy facility including development of Standard Operating Procedures and business processes supporting quality assurance investigations and product complaints.

Education And Experience

• B.S. in a life or physical science related discipline (equivalent industry experience will also be considered).
• Minimum of 4 years of pharmaceutical experience or related GMP industry. Previous people or team leadership experience is desired.

WORKING CONDITIONS

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

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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

Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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 to [email protected]. Visit careers.bms.com/eeo-accessibility to 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.