Assoc Director, BI&T Compliance & CSV- Devens MA

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
• 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