Senior Manager, 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 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

The QA Compliance Materials Management Senior Manager will be responsible for leading the material qualification program for both the drug substance and drug product facilities and leading the site's Quality Risk Management (QRM) program here in Cruiserath Biologics. The Senior Manager will also be responsible for managing a team and ensuring compliance with regulatory requirements.

Due to the nature of the role, the Senior Manager, QA Compliance (Materials Management) may work in other and/or multiple QA areas once the appropriate training has been completed. Their responsibilities may include some or all as outlined below.

Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs

Key Duties and Responsibilities:

• Act as the Local Process owner for the Material qualification program on site and represent Cruiserath within the global L2 group function.
• Develop and implement policies and procedures for material qualification, ensure compliance with regulatory requirements, and manage the overall process of material qualification for both the drug substance and drug product facilities.
• Develop, maintain, and manage the material certification requirements and Direct Dispense program for drug substance and drug product facilities.
• Lead a team who will manage the release for use all raw materials, working cell bank and where applicable consumables for use in the plant.
• Act as the Site Quality Risk Management (QRM) Lead. The QRM lead is responsible for leading the QRM program across the site, which includes identifying, assessing, and managing risks associated with the organization's products, processes, and systems.
• The QRM lead is responsible for collaborating with other departments to ensure that QRM activities are integrated into the organization's quality management system.
• People Management: Manage a team, set performance goals, provide coaching and feedback, conduct performance evaluations, and manage employee development and training.
• Compliance Oversight: Ensure that all activities related to material qualification and QRM are conducted in compliance with applicable regulations and guidelines. Monitor compliance, identify areas of non-compliance, and develop and implement corrective actions as needed.
• Support the SDP facility through start up to pre-approval inspection (PAI) readiness and into commercial biologics drug product manufacture.
• Support QA Compliance team inspection readiness team for self-inspection, Health Authority, corporate or customer inspections.
• Cross-Functiona