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.

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, 2021 and 2022.  

Position Summary

BMS Cruiserath Biologics is seeking to recruit a permanent Manager, QA Compliance. Reporting to the Senior Manager, QA Compliance, the Manager, QA Compliance will support quality and regulatory compliance for the BMS Cruiserath Biologics Manufacturing campus.

Key Responsibilities

• Maintenance and update of site compliance documentation, including but not limited to:
  • Manufacturing Authorizations
  • Site Master File (and associated appendices)
  • Supply Chain Flow Maps
  • Product Specification Files
• Site support for regulatory activities for new marketing authorization (MA) applications and product launches.
• Coordinate the Site Inspection Readiness and PAI Readiness programs.
• Coordinate the review of CMC sections of licenses related to site activities.
• Support the co-ordination of recall activities for the Cruiserath Biologic site.
• Lead Regulatory Surveillance for the site.
• Liaise where applicable on any Product Defect Notifications.
• Lead the Notification to Management Process for significant events and support the process of quality defect reporting with applicable Health Authorities.
• Work as part of a team dealing with global registrations and providing regulatory support to all operational departments on-site and in conjunction with the global regulatory affairs organization.
• Author/Update Quality Agreements with internal sites, Alliance partners and suppliers.
• Authoring, review and approval of QA-related procedures.
• QA review, assessment and approval activities for Biologics Manufacture, as applicable, for:
  • Change controls
  • Deviations/Investigations
  • CAPAs
  • Other associated documentation
• Maintain a sound knowledge of European & US and rest of world regulatory requirements to provide advice and expertise on-site and cross-training to colleagues on regulatory matters.
• Be a core team member of the QA Systems & Compliance team engaging in other support activities as required.

Qualifications & Experience
BSc in Science or related discipline with a minimum of 5 years’ Quality or Regulatory experience in a Biologics or Pharmaceutical environment.

A clear understanding of cGMP requirements for Quality Compliance and/or manufacturing.

Detailed knowledge of Biologics Processing would be a distinct advantage.

The successful candidate will be required to work on their own initiative in addition to working as part of a team. Excellent communication, presentation, time-management and organizational skills are essential.

Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level.

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 an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym

#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 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

BMS has a diverse 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 [email protected]. 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.