Senior Manager, Computer Systems Validation

Bristol Myers Squibb • Summit, NJ

2d

About The Position

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. 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. Senior Manager, Computer Systems Validation (CSV) – Cell Therapy Location: Summit, NJ Department: Equipment Commissioning and Qualification Organization Position Summary The Senior Manager, Computer Systems Validation (CSV), Equipment Commissioning & Qualification supports design, development, delivery, validation, maintenance, and support of GMP computerized systems at multi-use sites. This individual interacts with internal team members, peer-level customers, and external service providers, supporting multiple projects and ongoing activities to ensure regulatory compliance. The Senior Manager supervises contract and/or full-time staff to facilitate departmental deliverables and directly supports CTDO Summit.

Requirements

• BS in Computer Engineering, Computer Science, or related discipline preferred.
• Minimum 10 years’ experience in a GMP environment.
• Minimum 7 years’ experience in pharmaceutical computer systems validation in a GMP environment.
• Minimum 5 years’ experience managing personnel and/or projects.
• Experience interacting with regulatory agents and auditors in compliance audit environments, including direct face-to-face interactions.
• Thorough knowledge of cGMP in the pharmaceutical industry.
• Advanced computer skills with demonstrated knowledge of validating computer systems used in the pharmaceutical industry.
• Strong problem-solving, verbal, and written communication skills.
• Ability to work independently.
• Strong interpersonal skills, team orientation, and professional maturity.

Responsibilities

• Lead a team of up to 9 people.
• Interview and hire internal/external personnel as needed.
• Provide direction to team members.
• Set individual and team contributions.
• Ensure appropriate training for all team members.
• Promote safety and adherence to site EHS procedures and guidelines.
• Ensure full compliance with BMS policies and procedures.
• Staff team appropriately and ensure technical competence across equipment technologies and groups.
• Manage and allocate resources for CSV activities on laboratory and manufacturing computerized systems.
• Provide technical input for validation deviations, technical assessments for change requests, and identify qualification/validation requirements for GMP compliance.
• Assist in design, analysis, execution, and approval of IQ, OQ, PQ, and UAT protocols and reports.
• Perform technical reviews of validation deliverables.
• Develop technical support manuals and address system troubleshooting pre and post system release.
• Build and manage a team capable of learning and configuring new applications, system architectures, and instrumentation.
• Identify regulatory gaps and provide technical/procedural mitigations.
• Address technical and compliance challenges across the System Validation Lifecycle; research, test, and generate solutions.
• Perform 21 CFR Part 11 and system risk assessments.
• Define needs, benefits, and technical strategy within the project life-cycle and processes.
• Ensure CSV resources are knowledgeable of latest industry regulations and initiatives.
• Lead Continuous Improvement efforts for the program.
• Promote and provide excellent customer service and support.
• Provide technical support and guidance on equipment and computer systems qualification and validation issues.
• Foster a positive team environment within the Equipment Commissioning & Qualification department and with site customers.
• Ensure computerized standalone systems are implemented and maintained in compliance with regulatory requirements.
• Serve as subject matter expert during internal audits or external regulatory inspections.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
• The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level