Senior Specialist, QC Quality Systems

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 Biologics is seeking to recruit a Senior Specialist, QC Quality Systems (Lead Investigator) on a permanent basis, reporting to the QC Shared Services Manager. The QC Quality Systems Senior Specialist will be part of a team who are responsible for supporting the Quality Control team with Investigations and Change Controls

Key Duties and Responsibilities:

• Lead and manage QC Investigations assigned
• Facilitate root cause analysis and problem solving sessions
• Complete the generation of associated investigation reports
• Determine and create CAPA’s, Effectiveness Reviews, and Supplemental Tasks as required
• Present investigations at IRB to senior management
• Leading and coordinating the initiation, implementation, and closure of QC Change Controls
• Ensuring the timely completion of all activities related to these quality systems
• Collation of metrics/KPI’s and generation of associated dashboard read-out
• Communication with BMS local and global stakeholders
• Lead huddles, meetings, conference calls and provide read-outs
• Participate in the OpEx strategy and support process improvements
• Participate in internal and external audits
• Support additional QC shared services activities, as required

Qualifications, Knowledge and Skills Required:

• Proficiency in communication and collaboration at a variety of levels
• Proven success working well in a team environment with flexibility to react to changing business needs
• Demonstrated problem solving, project management ability
• Excellent time management and organizational skills
• Excellent technical writing skills
• Previous investigations experience is an asset.
• Ability to research and have an excellent understanding of new areas/tasks/assays under investigation promptly
• Education minimum of a B.Sc. Biochemistry or related discipline
• At least 3 years’ experience, in a GMP laboratory setting ideally within a biologics laboratory
• A minimum of 1 years’ experience with demonstrated effectiveness using quality systems (investigations/change controls – Trackwise/Infinity) in a FDA and EMA regulated environment
• Knowledge of biologics QC testing (Separations, Bioanalytical, Microbiology, Raw Materials and Stability testing) is desirable

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
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