Manager, Quality Assurance, Quality Engineering and Validation (QEV)

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.

• Mentor and be a resource for 1-3 junior coworkers or contractors

• Review and approve complex documentation in support of GMP operations at JuMP, including but not limited to facility plans, validation and other technical protocols and reports, trend reports, risk assessments, standard operating procedures, CAPAs, deviations, etc.

• Provide Quality oversight of process validation studies and process performance qualifications.

• Provide oversight of cleanroom lifecycle programs including aseptic process simulations, environmental monitoring performance qualification, cleanroom certification and recertification, cleaning and sanitization, and facility controls.

• Proactively identify and resolve technical and compliance issues/gaps.

• Provide support to multiple areas within and, potentially, between facilities, requiring a high level of regulatory, Quality System, facility, equipment and process knowledge.

• Ensure adherence to internal procedures and industry/regulatory expectations related to facility/equipment controls and release before, during and after production operations (i.e. routine operations – calibration/maintenance, shutdowns, construction projects, etc.).

• Collaborate with stakeholders within and outside of the JuMP Manufacturing Facility, and communicate equipment, facility and system status; monitor progress and issue status reports.

• Act as Quality Engineering Subject Matter Expert for responsible areas/projects during regulatory inspections.

Experience

• Bachelor’s degree in a STEM discipline, additional disciplines may be considered if combined with relevant experience.

• Minimum of 7 years working in a Quality, Engineering, Manufacturing role (or combination thereof) within a commercial biopharmaceutical, cellular therapy, or gene therapy organization.

• Direct experience with providing Quality Engineering guidance and support in a commercial biopharmaceutical, cellular therapy, or gene therapy organization strongly preferred.

• Experience with Equipment, Facility and Utility Qualification and/or Process Validation in a biopharmaceutical environment.

• Experience in Systems related to validation, calibration, maintenance, change control, and deviations strongly preferred.

Knowledge, Skills, and Abilities

• Knowledge of cGMP regulations, automation standards, FDA, EMA and PMDA guidelines applicable to biologics and cell therapy.

• Strong individual contributor with demonstrated ability to work independently.

• Detail oriented, with strong GMP Quality and Engineering experience.

• Experience in developing/optimizing Quality Systems related to validation, calibration, maintenance, change control, and automation strongly preferred.

• Excellent communication, trouble shooting, and problem-solving skills.

#LI-Onsite

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.

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