Duties/Responsibilities- Lead the Campus IT Compliance and CSV team
- Promote a safe and compliant environment and mindset.
- Select, develop, coach, and manage the Devens Campus IT Compliance and CSV team.
- Set goals, objectives, and contributions of the Campus IT Compliance and CSV team.
- Drive continuous improvement of team productivity and KPIs.
- Ensure the team delivers critical projects on time.
- Act as a liaison between site stakeholders and enterprise/business application teams to ensure business continuity is maintained.
- Manage service providers and ensure alignment with contractual SLAs.
- Engage and support PBRG teams in support of the BMS culture.
- Act as the Computer System Validation (CSV) process owner onsite
- Provide guidance to Digital Plant and site functional groups on CSV process implementation.
- Participate actively with other groups to analyze and address process deficiencies.
- Support the BMS Data Integrity and Quality Risk Management programs.
- Lead campus-wide IT compliance support and project execution
- Ensure appropriate support for GxP business operations across the Devens campus.
- Define, implement, and track Service Level Agreements (SLA) for supported business-critical activities.
- Collaborate with Devens Digital Plant leaders to address issues and develop plans to reduce support volumes across the site.
- Manage organizational adoption of BMS standard processes and systems, including ServiceNow, and continuously enhance processes to simplify support requirements.
- Foster business and enterprise partner relationships to ensure a high customer satisfaction rating.
- Represent Digital Plant during internal audits and regulatory inspections.
- Ensure that procedures, guidance documents, and other GxP-related documents are maintained in a high state of compliance and audit readiness.
- Ensure the validation, implementation, and change management of regulated IT systems used across the site are conducted in compliance with applicable regulatory requirements.
- Participate actively with other groups to analyze and address process deficiencies, working collaboratively with peers in Validation, Manufacturing, Engineering, Quality, and Digital Plant.
- Effectively track project progress to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
- Provide updates to management through established tools and project dashboards.
- Pursue innovative solutions.
- Periodically review, specify, and revise regulated IT systems supporting site operations.
- Follow industry trends and innovation, finding new technical solutions to meet evolving business needs.
- Evaluate vendor recommendations and lessons learned from other BMS sites.
Requirements- Bachelor's degree in Engineering, Information Technology, Computer Science, or related field, with a minimum of 12 years of experience in pharmaceutical quality operations, quality assurance, quality systems, computer system validation, and/or IT compliance roles.
- Proven leadership skills and track record of success in managing regulated IT compliance and validation initiatives.
- Demonstrated leadership skills in coaching, managing, and mentoring staff members, including effective team selection and personnel management.
- Expertise in 21 CFR 210, 211, and 11, and GAMP standards for validation of automated systems is required; a high level of understanding and experience in computer system validation and qualification principles is required.
- Knowledge of Quality principles, system development lifecycles, and QA methodologies, such as ISO 9001.
- Experience with IT oversight of electronic systems supporting GMP operations is required.
- Demonstrated ability to work effectively with US FDA and other regulatory agencies.
- Substantial knowledge of QSR, GMP, FDA, GAMP, ISO, ICH, and other applicable standards and guidance regimes.
- Experienced documentation and technical writing skills.
- Excellent technical troubleshooting abilities.
- Demonstrated creative problem-solving skills.
- Ability to lead highly effective teams both at a local site level and across the network.
- Strong collaboration and cross-functional leadership skills to drive continuous improvement, promote knowledge sharing, and implement best practices across the network.
Compensation Overview:Devens - MA - US: $176,720 - $214,137
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- 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.
*Eligibility Disclosure: 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.
