Associate Director, Quality Engineering (MES/LES harmonization)

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 AND SCOPE OF POSITION:

• Quality oversight of shared manufacturing instructions across multiple CT mfg sites. Specific examples include, but are not limited to:

  • Owns MES standard reports (i.e. batch report)

  • Defines Batch Record signature requirements (perform, review, verify, approve)

  • Quality decision owner for change requests to MES, electronic batch record components, and shared Operational instructions (SOPs, Work Instructions, etc.)

• Quality oversight for shared testing instructions across multiple CT mfg sites. Specific examples include, but are not limited to:

  • Owns LES standard report(s) – (i.e. certificate of analysis)

  • Defines test method signature requirements (perform, review, verify, approve)

  • Quality decision owner for change requests to LIMS (e.g. CeLabs) and electronic test methods

• Quality representation in communities of practice (CoP) with site end users to make data-driven decisions about continuous improvement to shared manufacturing and testing instructions.

The starting compensation for this job is a range from $149,000 – $188,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation is decided based on demonstrated experience. For more on benefits, please visit our BMS Careers site. Eligibility for specific benefits listed in our careers site may vary based on the job and location.

#LI-Onsite #BMSCART #Veteran

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

• Demonstrated proficiency with either manufacturing operations, obtained by direct experience in Manufacturing Operations or Manufacturing Science and Technology, or testing operations, obtained by direct experience in Quality Control Operations or Analytical Science and Technology.

• Demonstrated proficiency with risk-based decision making. Experience with ICH Q9 risk management lifecycle from Assessment, Controls and Review.

• Experience with continuous improvement, such as six sigma or LEAN methodology is required.

• Experience in quality Operations, obtained by direct experience with batch record review and product release is preferred.

• Experience as subject matter expert during health authority inspection is preferred.

• Ability to lead cross-functional teams in a matrix environment where combined contribution, collaboration, and time bound results are expected. Successful candidates must be able to provide and receive peer feedback in a positive fashion. Role requires extensive cross-functional collaboration with representatives of Manufacturing, Quality Control test labs, IT, MSAT/AS&T and other functions.

EDUCATION AND EXPERIENCE

• Bachelor’s degree is required, with a preference for Science or Engineering.

• Ideal candidate will have a minimum of 10 years of directly relevant experience in a combination of Manufacturing or Testing and Quality Operations roles. Experience in a regulated cGMP environment is required.

WORKING CONDITIONS: OFFICE & cGMP SPACES (US Only)

• Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

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 the resources to pursue their goals, both at work and in their personal life.

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.

COVID-19 Information
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.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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 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.