Manager, IT Quality and Compliance, Cell Therapy

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 Manager, IT Quality and Compliance, Cell Therapy Facility (CTF) role will provide support to the Digital Plant team in Devens CTF through managing the computerized system validation (CSV) activities / major projects and supporting deviations and change controls related to computerized systems.

This position work closely with the Digital Plant (IT/Automation) subject matter experts and other key stakeholders, such as Manufacturing Science and Technology, Quality, Manufacturing Operations, and Validation.

Major Duties & Job Responsibilities:

• Gain a thorough understanding of computer systems deployed at Devens Cell Therapy Facility (CTF) at Devens campus.
• Act as CSV Subject Matter Expert (SME) for computerized system related changes and associated IT/Automation projects – advising operations on CSV matters and defending their work before regulatory agencies.
• Manages CSV program, ensuring standardization and consistency of qualification testing documents and associated testing deviations.
• Review and approve qualification documents as part of CSV activities, supporting the pre- and post-approval of qualification testing.
• Participates in regulatory audits as Digital Plant representative and assists in generating responses to audit observations.
• Provides IT quality support to Devens CTF Digital Plant team through quality review and approval of investigations or change controls, deviation ownership of computerized system events, and CSV activities.
• Interact with Infinity (Change Management system) to enter deviations and associated actions, investigations and associated root cause analysis, supporting data, corrective action/preventative action (CAPA) and effectiveness reviews as needed.
• Provide quality support of Digital Plant programs and system maintenance activities.
• Perform project audits as the needs arise.
• Ensure that Digital Plant standard operating procedures (SOPs) and procedural methodologies employed to maintain the validated state are regularly reviewed and updated, as needed.
• Assist in development of appropriate validation methodologies in collaboration with Operations Management and Quality Assurance for novel projects.
• Provide CSV input to multi-function teams, advises operations on CSV matters, and defend their work before regulatory agencies.
• Duties may include internal compliance or efficiency improvement efforts within department.

Knowledge & Skills

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
• A minimum of five (5) years of relevant experience in a regulated environment with at least four (4) years focused on quality assurance, validation or compliance for computerized systems.
• Knowledge of various Manufacturing IT systems such as: Process Automation System (DeltaV), Manufacturing Execution Systems (Syncade), Data Historians (OSI PI), Enterprise Resource Planning (SAP), Laboratory Information Management System (Celabs) is preferred.
• Knowledge of various GxP supporting systems, such as Quality Management System (Infinity) and Document Management Systems (CelDox) is desirable.
• Knowledge of paperless validation systems, such as ValGenesis is preferred, not required.
• Experience working in a team-based environment with a diverse group of people.
• High quality assurance mindset with Quality Assurance experience in the computer system and pharmaceutical computerized systems field and understanding of quality risk management principles.
• Understanding of SOPs, cGMPs and other compliance requirements including guidelines within a regulatory environment (FDA, EU).
• Proficiency in project management, oral communication, and technical writing skills are required.

Decision Making

• Exercises sound judgment in making decisions and recommendations. Routinely makes decisions and takes or influences action on typical and atypical cases. Works on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Erroneous decisions or failure to achieve results will have significant financial implications, compliance implications or cause significant delays in schedules.
• Coordinates with higher level IT Quality personnel on decisions and applies appropriate notification to management as appropriate.

Supervision Received

• Incumbent typically manages a complete function or process, either through staff, the coordination of a team, or individual efforts. Receives assignments in the form of objectives and establishes goals to meet objectives. Work is measured based on meeting established objectives and schedules.
• Receives assignments which require the application of a defined process to complete the assignment. As such, specific assignments are allocated based upon the recipient’s demonstrated capabilities with the degree of supervisory attention determined accordingly.

Contacts

• Work both independently and in a team environment at all levels of the organization, in particular Digital Plant, MS&T, Validation, Quality and Manufacturing Operations.

Working Conditions

• Work within Site Facilities, which requires one to give a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE). May work on cross-site initiatives to drive policy.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

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 if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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