Manager, QA Manufacturing Operations

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 and 2021.  

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

The Role

BMS Cruiserath Biologics is seeking to recruit on a permanent basis a Manager, QA Manufacturing Operations - Extended Days.

Reporting to the Senior Manager, QA Manufacturing Operations, the Manager, QA Manufacturing Operations - Extended Days will support the execution and maintenance of the QA activities related to Manufacturing operations and site operations on Extended Days in Cruiserath. The Manager, QA Manufacturing Operations - Extended Days is responsible as required for the implementation and operation of all Quality Management Systems and Operational activities for the Multi-Product Cell Culture (MPCC) facility at Cruiserath Biologics. Due to the nature of the role, the Manager, QA Manufacturing Operations - Extended Days may work in other and/or multiple QA areas once the appropriate training has been completed. This role requires weekend work as per the shift rota. Their responsibilities may include some or all as outlined below:

Key Duties and Responsibilities:

• Lead QA manufacturing operations on shift in support of commercial operations and new product introductions

• Allocate the day-to-day tasks within QA Manufacturing Operations on shift as per the team role cards.

• Shift trainer for core QA Manufacturing Operation procedures and OJTs.

• QA Operations Approval of significant events and investigations; Change control assessment & approval and CAPA evaluation/CAPA close-out

• Support MT & MS&T Reports / Protocols for Commercial activities e.g. Risk Assessments; Sample Plan justification etc.

• QA SME for trouble shooting/resolution during/post start-up.

• Provide expertise, mentorship and training to Senior Specialists, QA Manufacturing Operations in relation to the day-to-day operations.

• Support and lead key meetings on behalf of QA Manufacturing Operations on shift.

• Lead and implement Lean Manufacturing principles & Support OpEx programs and champion continuous quality improvement initiatives.

• Batch record review and on the-floor support of manufacturing activities

• Authoring, review and approval of QA-related procedures

• Review and approval of functional area documentation

• Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.

• Engage in Quality Culture initiatives

This is a 12/7 shift role.

Qualifications, Knowledge and Skills Required:

• BSc in Science or related discipline with a minimum of 5 years’ QA Operations or related experience in a Biologics or Pharmaceutical environment

• A clear understanding of cGMP requirements for manufacturing and/or systems and compliance

• Detailed knowledge of Biologics Processing would be a distinct advantage.

• Required to work on his/her own initiative in addition to working as part of a team.

• Must be able to work across a team matrix in order to meet accelerated timelines

• Excellent communication and presentation skills are essential

• Excellent time management and organisational skills along with a proven ability to multi-task

• 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, 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.

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.