Senior Specialist, QA Compliance Materials Management

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 looking to hire a Senior Specialist in QA Compliance for Materials Management on a 12-month temporary fixed-term contract. Reporting to the Senior Manager, QA Compliance Materials Management, the Specialist will support the material qualification and release activities for the Cruiserath manufacturing facility for its biologic’s commercial portfolio and clinical pipeline. 

Key Responsibilities

• Preparation, review and approval of Material Qualification Documentation.

• QA disposition of raw materials, level 1 & level 2 consumables.

• Authoring, review and approval of QA-related procedures.

• QA review, assessment and approval activities for Biologics Manufacture, as applicable, for:

  • Change controls

  • Deviations/Investigations

  • Supplier Investigations

  • CAPAs

  • Supplier Change Notifications (SCN)

  • TSE (Transmissible Spongiform Encephalopathy) Certificates

  • Other associated documentation

• Be a core team member of the QA Compliance Materials Management team engaging in other support activities as required.

• Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Qualifications & Experience

The successful candidate must possess:

• BSc in Science or related discipline with a minimum of 3 years’ QA or related experience in a Biologics or Pharmaceutical environment

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

• Knowledge of material qualification & SAP 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 to meet accelerated timelines.

• Excellent communication and presentation skills are essential.

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

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

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.

Why you should apply

• You will help p