**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 . **PURPOSE AND SCOPE OF POSITION:** The Associate Director, CTF Digital Plant IT Quality at Devens Cell Therapy Facility (CTF) will direct the development, implementation, and maintenance of IT/Automation (Digital Plant) processes and ensure the group's adherence to System Life Cycle standards. This role also owns the IT Compliance, IT Deviation Management, Computer System Audit Program, Change Management, Risk Management Program, as well as the Computer System Validation Program at the Devens CTF. This role will lead a matrixed organization composed of site direct reports, indirect reports, as well as contractors to deliver the goals and objectives. This role will interface with global compliance, validation, and deviation management initiatives to ensure alignment as well as represent the site in those initiatives. **REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities** + Thorough knowledge of regulatory computer system validation requirements including FDA, EMA, and Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to Cell & Gene Therapy or Biologics manufacturing. + Demonstrated knowledge of Quality principles and QA methodologies including GAMP and ISO 9001. + Mastery of site and global SOPs, cGMPs, compliance requirements, regulatory guidelines (FDA, EU) and the technical acumen to work and manage within a regulated environment. + Proven experience in designing and implementing quality systems, risk management systems, audit readiness programs, deviation management program, change management and program elements required to manage the system lifecycle of a fully automated, multi-product, Cell Therapy manufacturing facility. + Demonstrated competency required to represent the department before stakeholders, external regulatory agencies, and management. + Demonstrated ability to manage a high performing team that encourage accountability and inclusion to influence behaviors and performance including excellent conflict management skills. + The ability and flexibility required to lead and encourage peers and team members to drive results in a fast-changing environment. + Excellent project management, communication, and technical writing skills. + A working understanding of Lean Six Sigma and OPEX principles. + Demonstrated ability to establish effective process performance (KPI) metrics for quality systems and programs. + Ability to develop and apply new and innovative approaches to projects and processes. + Ability to understand business needs and synthesize solutions across functions. + Must be able to influence others in matrix environment. **DUTIES AND RESPONSIBILITIES** + Leads the IT Compliance, IT Deviation Management Program, Computer System Audit Program, Change Management, Risk Management Program, as well as the Computer System Validation Program at the Devens CTF. + Leads a high-performing Digital Plant Quality team by effectively managing team culture, skills, performance management, goal-setting, coaching, people development, priorities, and workload for the Digital Plant Compliance and Computer System Validation teams. + Member of the Digital Plant Leadership Team collaborating on the department vision, quality strategy, goals and culture while undertaking supportive actions which drives commitment to these values, objectives, and sustained site-wide teamwork. + Provides mentorship and leadership influence at all levels of the organization including within Digital Plant, Quality, Validation, MS&T and Manufacturing Operations teams. + Influences internal and external stakeholders to ensure operational decisions and business requirements have a positive impact on Digital Plant and BMS. + Directs external vendors tactically and provide strategic input to vendors on services delivered. + Recommends pursuing actions based on impact on people, technology, structure, and/or workflow. + Develops and implements proactive approaches to new technologies and processes. + Participates in regulatory audits and internal audits as the Digital Plant representative and responsible for generating timely responses to audit observations. + Owns the Digital Plant Quality Training Program to support procedures where necessary. + Ensures alignment with BMS directives and industry guidelines on Digital Plant issues. + Provide CSV subject matter expertise (SME), to multi-function teams, advises operations on CSV matters, and defends their work before regulatory agencies. + Review and approve Computerized Systems qualification documents, as required. + Ensure that SOP's and procedural methodologies employed to maintain the validated state are regularly reviewed and updated as needed. + Analyzes current processes and procedures to identify gaps and shortcomings in collaboration with Digital Plant Leadership Team members as well as business functions to propose process improvements and document such in appropriate procedures. + Leads internal compliance and/or efficiency improvement efforts within the department. + Works on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in analyzing problems and developing recommendations. + Acts as an advisor to superiors, peers and subordinates and becomes actively involved to meet schedules or resolve problems. + Works with minimal supervision on the accomplishment of agreed upon goals and objectives. **EDUCATION AND EXPERIENCE** + Engineering and science experience generally attained through studies resulting in a B.S. in Engineering, a related IT/OT discipline or its equivalent. + Experience managing high performing teams. + Experience leading Compliance and Computer System Validation (CSV) projects. + A minimum of 8 years of the above relevant experience in the biopharmaceutical industry or its equivalent. **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 or enterprise initiatives to drive policy. + This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. 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. **Uniquely Interesting Work, Life-changing Careers** With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. **On-site Protocol** BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. **Company:** Bristol-Myers Squibb **Req Number:** R1584736 **Updated:** 2024-11-13 03:12:21.881 UTC **Location:** Devens-MA Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.