Assoc Director, BI&T Compliance & CSV

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.
  • Able 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.