Manager, Quality System, Change Controls

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.

Bristol-Myers Squibb in Summit, NJ is searching for a remarkable Manager, Quality Systems Change Controls to join our phenomenal team! As our Manager, Quality Systems Change Controls for the Summit Cell Therapy Manufacturing facility, you will support the business process owner for Change Control module and the associated governing local procedures and supporting processes. This is a highly visible role with site responsibility and cross-functional influence that has impact on departmental performance and broad quality change control management. The incumbent will serve as the subject matter expert for the Change Control process across the site.

Role Responsibilities:

• Manages the Change Control Quality System for all GMP activities and works with responsible cross functional areas ensure timely completion.

• Run the Change Control Review Board and governance tracker meetings, generate meeting minutes, follow up on action items and facilitate resolution when required.

• Review and approve change controls for appropriateness and ensure records are in compliance with regulatory requirements and internal procedures.

• Compiles applicable process metrics, identifies trends and escalates accordingly.

• SME support during internal and health authority inspections of facility.

• Communicates effectively with cross functional stakeholders on matters related to change control process.

• Supports Quality Systems harmonization efforts.

• Performs other tasks as assigned.

Role Requirements:

• Bachelor’s Degree required.

• 6-8 years of related Quality experience in the pharmaceutical, medical device, or healthcare industry.

• Experience working with Quality Systems documentation.

• An equivalent combination of education and experience may substitute.

• Must have experience with cGMP manufacturing, Quality, and Compliance.

• Must have strong authorship and be able to critically evaluate change controls and generate technical conclusions consistent with Quality risk management principles.

• Must be able to routinely recognize quality issues and interpret problems, as well as propose solutions for complex issues.

• Must understand continuous improvement and be able improve the compliance and efficiency of the quality system.

• Must be able to effectively prepare and convey data analysis to management and others within the group with clarity and accuracy.

• Must be self-directed, complete routine tasks independently and be confident in making decisions in respective subject matter area, consulting with management for decisions outside of established processes.

• Requires moderate direction to complete more complex tasks.

• Comfortable providing input/guidance to others within the department and across the organization in change control technical writing.

• Propose solutions for issues and work with management to resolve.

• Comfortable providing training/guidance to system users as needed, and in instructor-led settings.

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

• Able to prepare written communications and communicate problems to management with clarity and accuracy.

• Able to support internal and health authority inspections of facility.

BMSCART, VETERAN

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.

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