Senior Manager, IT Quality & Compliance

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Senior Manager, IT Quality & Compliance – Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at multi‐use sites through interaction with internal team members, peer and higher-level customers as well as external service providers.

The individual is responsible for development of and adherence to system governance procedures. The individual supports multiple IT projects/systems and ongoing work activities of moderate to high complexity. The individual will answer questions and resolve IT issues for manufacturing and manufacturing support staff.

Reporting into the IT organization the candidate will be primarily responsible for managing IT deviations, CAPAs, Investigations and Change Management in support of the 24/7 Cell Therapy manufacturing site.

Responsibilities & Duties:

• Lead and manage IT Quality & Compliance for the 24/7 Cell Therapy manufacturing site.

• Take ownership of deviations, CAPAs and investigations involving the Manufacturing IT Systems.

• Open and lead investigations, triage deviations, and ensure CAPAs are addressed and implemented per requirements.

• Engage technical experts as needed to author and present change requests and author investigations write-ups.

• Support Health Authority and internal audits.

• Collaborate and support the other Site IT groups (Manufacturing IT Systems & MES, Operational Technology Systems & Automation, Enterprise Systems and Integration, IT Site Shared Services) to ensure we can correctly support the manufacturing site.

• Gain proficiency in the IT Service Management platform ServiceNow to create and track service requests, incidents, requests, problems, etc.

• Provide support for operationalizing the manufacturing and peripheral systems.

• Accountable for the continued compliance of IT systems, procedures and training for CAR-T manufacturing and lab systems.

Competencies: Knowledge, Skills & Abilities:

• Ability to effectively communicate with both technical and non-technical team members.

• Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.

• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.

• Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.

• Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow).

• Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).

• Familiarity with MES systems (i.e. Emerson Syncade), DCS systems (i.e. Emerson DeltaV, ERP systems (i.e. SAP or Oracle), EBRs (i.e. InfoBatch) and Historians (i.e. OSIsoft PI).

• Understanding of computer system validation (CSV).

Required Experience:

• Bachelor’s degree in an Engineering or MIS discipline.

• Must have experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment.

• Must have 10+ years of hands-on experience in a biotech manufacturing and supply chain environment.

• Understanding of supply chain, manufacturing domains and supporting technology including manufacturing and supply chain ERP systems (e.g. Oracle, SAP).

• Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.

• Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE).

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or 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.