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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.
Additional Qualifications/Responsibilities
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.
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.
Compensation Overview:
Devens - MA - US: $176,720 - $214,137