Manager, Quality Engineering Cell Therapy

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. Take your career farther than you thought possible.

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Manager, Quality Engineering Cell Therapy, Bristol-Myers Squibb Company, Devens, MA. Provide quality oversight on computer system lifecycle documents, commissioning and qualification lifecycle documents, risk assessments and strategies. Review and approve validation plan, qualification plan, data migration plan, data integrity risk assessment and Electronic Records & Electronic Signatures (ERES) Assessment in compliance with Food and Drug Act (FDA) regulations and company policies. Review and approve system risk assessment documents and ensure all mitigation strategies are developed and implemented for potential risks. Review and approve requirement specifications in validating new or modified processes, systems that supports manufacturing in the plant i.e., User Requirements Specification, Functional Specification, System configuration specification, Design specification, using extensive working knowledge of quality concepts and internal procedures. Support planning of validation testing activities and test strategy. Coordinate and execute the overall protocol process, including test case creation/pre-approval (installation /operational /performance qualification), test case post execution reviews/approval. Review and resolve protocol discrepancies associated with the qualification and startup of the Devens cell therapy facility and participate in resulting investigations and correction / corrective action planning. Release of systems for GMP use upon review/approval of system summary reports such as qualification protocol final reports, data migration reports, system validation report and requirement traceability matrix. Review and approve the periodic review reports to validated/qualified systems and assists with the identification of issues/trends and subsequent actions necessary to maintain the system's validated/qualified status. Support site deviation investigations and complete implementation of Corrective Action and Preventive Action (CAPA) actions. Responsible for maintenance of the site technical review board and IT change management process, assuring consistency with establishing standards for local and global change control systems. Ensure that all regulatory and cGMPs compliance items related to validation are satisfied and ensures validation master plan (VMP) adherence. Verify compliance with applicable BMS Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications. Provide technical responses to audit inquiries and inspections from world health authorities on validation approach, protocols, validation master plans, project plans and Standard Operating Procedures (SOPs).

40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m. $127,308 - $142,670/yr.

MINIMUM REQUIREMENTS:

Master’s degree or foreign equivalent degree in Chemistry, Information Technology, Science or a related field, and four (4) years of post-baccalaureate work experience as a Validation Engineer, Quality Engineer, or related. In the alternative, the employer will accept a Bachelor’s degree or foreign equivalent degree in Chemistry, Information Technology, Science, or a related field plus six (6) years of post-baccalaureate experience as a Validation Engineer, Quality Engineer, or related.

Must have experience with/in:

• Regulatory requirements, including current Good Manufacturing practices (cGMP), Good practices (GxP), including 21CFR part 11, and Good Documentation practices (GDP);
• Life cycle documents, manufacturing methodologies/principles, cell therapy process;
• Application lifecycle management (ALM), electronic execution system and Quality Management systems (QMS);
• SAP, Laboratory Information Management system (LIMS), Maximo, manufacturing executions systems (Syncade), distributive control systems (DeltaV); and
• Pl Historian.

The required skills do not need to be maintained over the full term of required experience.

Any suitable combination of education, training or experience is acceptable.

May telecommute to Devens, MA, 50% of time from any US location.

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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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 a supportive culture, promoting global participation 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 an 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 to adastaffingsupport@bms.com. 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.

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