Senior Specialist QA Investigations

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

PURPOSE AND SCOPE OF POSITION:

• 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.
• 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.

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.
• 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 and QMS improvement activities.
• 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.
• Represents QA in cross functional meetings.
• Able to recognize conflict and escalate to management.
• Participates as requested in the response team for audits and inspections by world health authorities.
• Working knowledge of applicable business systems including SAP, LIMS/Celabs, Maximo and/or Veeva Vault.

DUTIES AND RESPONSIBILITIES

• 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.
• Reviews and approves investigations, corrections and actions associated with all areas of the manufacturing process including incoming, manufacturing, facility and utility systems.
• Provides quality support and oversight for Manufacturing Science and Technology and Validation protocols and reports.
• 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 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.
• Identifies and reports any EHS, Quality or Compliance concerns and takes immediate corrective action or escalation as required
• Represents QA in cross functional meetings.
• Provides training on QA owned procedures.

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.).

#LI-hybrid #CART

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

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

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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

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