IT Compliance Training and Document Control LeadApply Now
Location: Weston, Massachusetts 02142
Employment Type: Contract
- Primarily responsible for updating/maintaining information in the Learning Management System (LMS), helping to ensure that the current training needs of the IT Department are kept compliant and up to-date, and management/maintenance of the document hierarchy in the Document Management System (DMS).
- You will ensure IT Training and Document Control programs, initiatives, and commitments are compliant with corporate requirements and expectations. You will work directly with technical and business leadership and Quality teams across the organization to assess and respond to compliance requirements to ensure requirements are understood & maintained.
- Provide oversight to IT Training and IT Document Control QMS, assess current state and work with stakeholders on simplifying QMS for IT to bring more efficiency.
- Manage IT component of Document Management System (DMS) and provide administrative support to ensure document workflow lifecycle is completed in compliant manner.
- Lead IT Document Management initiatives, develop and manage hierarchy and related documentation to continuously improve the Document Management Program.
- Lead the strategic direction and continuous improvement of the IT GxP / Non-GxP Document Management program.
- SME in the LMS/DMS and provide training/support to users of the systems.
- Support development and rollout of Training Content and manage IT Training Curricula and Roles, Training profiles, and onboarding training. Ensure training is completed.
- Work with MSP/Vendors to make sure they are complying to IT Training and Documentations standards. Perform periodic checks and drive improvement activities.
- Assist quality during inspections as the IT Training and Document Control process owner.
- Track and resolve emerging inspection readiness gaps; develop remediation plans to mitigate compliance risks.
- Identify early trends and take majors to avoid compliance citations.
- Perform mock checks to determine IT Training and Document Control compliance readiness.
- Conduct training in GxP and QMS topics, to the wider IT community.
- Propose and implement KPIs that are meaningful measures and indications of the system and internal process performance. Analyze data and report any trends that arise. React to those metrics to ensure compliance with the training program.
- Manage complex and multiple projects, including developing timelines, milestones, responsibilities and overall stakeholder relationships
- Detailed knowledge in the application of CSV principles, GAMP cGMP, cGCP, 21CFR Part 11, and other regulatory requirements and industry best practices relating to GXP computerized system validation, infrastructure qualification, ITIL processes and system development life cycle activities.
- Project and people management skills and the ability to lead and work as part of a team; ability to maintain open and frequent communication with contractors and internal stakeholders.
- Professional experience in biopharmaceutical industry, including technological understanding of GxP systems, validation and qualification, risk management, root cause analysis and investigation management
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