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 of Position:

The Quality Engineering and Validation team at BMS is responsible for providing Quality Assurance oversight of environmental, equipment, utility and facility, site automation (site MES, InfoBatch, site LIMs as applicable), maintenance, process validation and engineering documents, test protocols, CAPAs, deviations, change control records, and additional site based technical documentation and activities. The Quality Engineering and Validation Associate Director is responsible for leading the Team, establishing processes and procedures and providing guidance inside the QEV department and to other departments as to the above activities.

Education:

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

Experience:

• 15 years of relevant biologics or cell therapy experience
• Minimum of 10 years working in a Quality, Engineering, or Manufacturing role (or combination thereof) within a commercial biopharmaceutical, cellular therapy, or gene therapy organization
• Minimum of 6 years of leadership experience including the supervision of direct reports.
• Direct experience with providing Quality Engineering guidance and support in a commercial biopharmaceutical, cellular therapy, or gene therapy organization strongly preferred.
• Experience with Process Validation and/or Equipment, Facility and Utility Qualification in a biopharmaceutical environment.
• Experience in Systems related to validation, calibration, maintenance, change control, and deviations strongly preferred.

Knowledge, Skills, and Abilities

• Proven proficiency in coaching and developing leaders is required.
• Knowledge of cGMP regulations, automation standards, FDA, EMA and PMDA guidelines applicable to biologics and cell therapy.
• 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.

Key Responsibilities

• Hiring, mentoring and developing leaders and senior individual contributors.
• Champion and foster a positive and successful quality culture, aligned with BMS culture
• Ensure staff are adequately trained and provide growth opportunities for department
• 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.).
• Build effective relationships to 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.

WORKING CONDITIONS (US Only):

• Equipment Usage During Work Period: Computer 80%; Phone and Electronic Devices 20%.
• Sitting at a computer for an extended period of time.
• Regular sitting, standing, talking, listening, using hands & fingers to operate a computer and telephone keyboard reach.
• Requirement to work in a conference room / meeting environment for moderate periods of time.
• Occasional periods in labs or production area, requiring some level of gowning.
• Light to moderate lifting.
• Regular, predictable attendance is required, plus occasional overtime, as business demands dictate.
• Moderate noise i.e. business office with computers, phone, and printers.

The starting compensation for this job is a range from $149,000 to $188,000, plus incentive cash and stock opportunities (based on eligibility). 

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 Careers 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.

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 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.

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