Manager, GxP Quality Documents & Record Management (Contract) 25652

Were seeking a Manager of GxP Quality Document and Records Management to cross-functionally to support the GxP documentation records management and training needs of business partners. Reporting to the Associate Director of GxP Document and Records Management this role acts as a strategic document control and training partner delivering high-impact document and training support experiences that meet both business and compliance needs.

The ideal candidate combines deep knowledge of GxP documentation and training best practices with strong project leadership document development and management acumen training needs assessment and a passion for driving operational excellence. This role will also manage cross-functional document initiatives and consult with internal teams to align on document strategy and performance outcomes.

Key Responsibilities:

Document Program Leadership

• Serve as SME for the GxP document process; provide consultation tools and support to enable consistent execution
• Partner with the Associate Director to evolve the document and records management quality system including the Document Management System (DMS) improvements and roadmap execution
• Monitor and analyze document program metrics and KPIs; identify areas for enhancement
• Own Quality Events (QEs) and CAPAs related to documentation and records management support audit and inspection readiness

Document Development and Management

• Provides oversight to the GxP document development and management process.
• Ensures process is compliant and meets global regulations.
• Reviews and Approves documentation to ensure it meets company and regulatory standards and requirements.
• Assists in the identification of functional and QA reviewers and approvers to assess documentation and records meet company and regulatory standards and requirements.
• Collaborates with internal business SMEs to analyze design and develop and manage documentation requested to support company initiatives.
• Implements communication strategies to ensure awareness and adoption of document related process changes.

DMS LMS & System Oversight

• Act as business administrator for the GxP DMS; manage system configuration validation and lifecycle
• Oversee all document and records lifecycle management within Document Management Systems (DMS)
• Act as a GxP Training Administrator for Learning Management System (LMS); create and maintains learning objects user groups curricula and learning assignments
• Manage training material workflows within electronic Document Management System (DMS)

Cross-Functional Partnership & Consulting

• Build strategic relationships with all GxP functions to align on documentation needs and compliance expectations
• Support document readiness for functional initiatives; lead or contribute to project teams as the GxP document SME
• Liaise with Document Owners QA Partners and Functional Area Leadership to ensure consistency and compliance across learning delivery
• Drive adoption of on-time periodic review compliance through communication planning change management and performance consulting

Qualifications:

Minimum:

• Bachelors degree with 4-8 years of experience in GxP Document and Records Management or a related function
• Strong expertise in DMS administration (e.g. Veeva DocCompliance Documentuum)

• Strong expertise in Learning Management System Administration within a GxP environment

• Deep knowledge of GxP regulations and quality systems
• Proficient in document development and management performance consulting and stakeholder engagement
• Demonstrated leadership skills and experience managing cross-functional training programs

Preferred:

• Experience with AI/Machine Learning project management platforms and learning analytics
• Strong communication facilitation and influencing skills
• Strategic thinker with ability to balance compliance with operational agility
• Comfortable managing multiple projects in a fast-paced highly regulated environment

$70-$75/hr

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other job-related factors permitted by law. In addition this role will be eligible for overtime pay in accordance with federal and state requirements

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