Associate Director, EMES Operational Excellence and Compliance

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.

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.

Bristol Myers Squibb Ireland

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units

Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility.  This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020 and 2021.  

For more information about Bristol Myers Squibb, visit us at BMS.com/ie

The Role

BMS Cruiserath is seeking to recruit on a permanent contract Associate Director, EMES Operational Excellence and Compliance, reporting to

Senior Director, Enterprise MES & Manufacturing Architecture, GPS BI&T

Product Acceleration & Capabilities IT

This role will provide oversight and support for operational excellence and compliance strategies for the BMS Enterprise Manufacturing Execution System (EMES) solution.  This individual will partner with the IT Quality and IT Validation teams and other cross-functional teams to ensure that systems comply will with all regulatory and cyber security expectations.   In addition to overseeing EMES operational and continuous improvement, the Associate Director of EMES Operation Excellence and Compliance will play a key role in EMES new site deployment and ongoing support across the BMS manufacturing sites.

Incumbent promotes and fosters an operational excellence culture, continuous improvement initiatives, aligning initiatives such as data integrity, end to end support, and cyber security controls for EMES core components across manufacturing sites to harmonize EMES strategy.

The Associate Director of EMES Operation Excellence and Compliance could be based in BMS offices in NJ or MA US or BMS Cruiserath, Dublin.

Key Duties and Responsibilities:

Operation Excellence

• Own and Develop Strategies: Develop and oversee the execution of overall EMES operation strategies. This includes, but is not limited to:

• • Tier meeting structure
  • Demand intake and workload management
  • Incident management
  • Crisis management
  • KPI management
  • Training design
  • Knowledge management

• Continuous Improvement: Drive continuous improvement by leveraging Agile, Lean, or other methodologies and innovative technologies, including but not limited to Artificial Intelligence.

IT Compliance & Methodology

• Quality and CSV Liaison: Act as the point of contact for quality and CSV organizations, overseeing validation and qualification activities for MES solutions.
• Validation Leadership: Lead EMES validation resources to deliver on commitments.
• IT Compliance Guidance: Provide overall IT compliance guidance to the EMES team, including Data Integrity, CSV practices, deviation management, change control, incident management, and investigations.
• Change Management: Define and own the EMES change management strategy, ensuring consistency between EMES and site operations.
• Global MES Design: Understand the Global MES design and work closely with the development lead and team to ensure that testing and deployment approaches, including SDLC and CSV testing, are aligned with development.

Development and Standards

• Standards Development: Collaborate with the development team to create standards that support recipe-driven manufacturing execution systems across the manufacturing network for all batch processing activities, from lab to patient.
• Scope of Standards: The scope of execution system standards includes project deployment (e.g., Playbook for EMES deployment and upgrades), recipe libraries, recipe management, process control, and data historian activities related to batch production, testing, release, and deployment.

Qualifications, Knowledge and Skills Required: ​

• Ten (10) or more years of experience in pharmaceutical quality operations, with at least 6 years' experience in GMP execution systems.
• Specific experience in process automation, MES and batch manufacturing industry standards (ISA S88 &S95)
• Experience with leading IT operation support, MES support is a plus.
• Expertise with 21 CFR Part 11 and GAMP standards for validation of automated systems is required.
• Experience with IT oversight of electronic systems for GMP operations is required. 
• Demonstrated excellence in written and verbal communication. 
• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
• Demonstrated ability to work effectively with US FDA and other regulatory agencies. Substantial knowledge of QSR, GMP, FDA, GAMP, ISO and other applicable standards.
• Demonstrated record with driving continuous improvement and fostering a compliant operational excellence culture.
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a leader of team(s) to engage and influence team members in a matrixed environment.
• Ability to travel up to 20% domestically and internationally (*when not restricted)

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.

BMSBL

#LI-Hybrid

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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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