Senior Manager, GxP Strategic Document Partner

Role Overview

• Serve as a Strategic Document Partner for assigned functional areas and/or quality system(s), aligning document development and records management with business, quality, and regulatory expectations
• Serves as a Process Documentation architect for the Global QMS
• Partners with Quality System Owners, Process Architecture and Digital Quality Systems to ensure documentation accurately reflects end-to-end process design, is structured for usability and compliance, and is fully integrated with training, systems and change management.
• Act as a liaison between functional area leadership and the GxP Document and Training Strategy and Operations teams, ensuring alignment of documentation goals with operational and quality objectives
• Conduct document impact and needs analyses and supports the functional document hierarchy which integrates the development, maintenance, and distribution of critical documents that support the organization’s strategic goals and initiatives to reduce documentation complexity and redundancy.
• Partner with stakeholders to ensure the document and records management process along with documentation assumes a risk-based approach and reflects current industry and regulatory standards
• Collaborate with QSO, Process Owners (PO), Document and Training Operations, and functional area partners to support inspection-ready documentation and records.
• Leverage automation, digital tools, and emerging technologies, including AI and Machine Learning, to optimize documentation processes and content to improve usability and accessibility of documentation
• Identify opportunities to enhance document and records management processes, content, and delivery methods by leveraging feedback and data-driven insights
• Promote a culture of change by driving continuous improvement initiatives that improve documentation impact and efficiency
• Evaluate documentation quality system effectiveness using appropriate metrics to ensure objectives are met and compliance requirements are achieved
• Support the Documentation QSO and PO in implementing the strategic documentation and records management roadmap by overseeing the development and delivery of document initiatives
• Collaborate with Strategic Document Partners to ensure consistent and effective application of best-in-class practices across the organization
• Serve as an escalation point for operational challenges, providing solutions to support uninterrupted document operations
• Collaborate with leadership to troubleshoot and resolve document-related issues effectively
• Partner with Strategic Learning Partners to oversee GxP document control processes related to training, ensuring accuracy, accessibility, and compliance of training materials
• Partner with Continuous Improvement to streamline processes

Requirements

• Bachelor’s degree with 5-10 years’ experience in GxP Document and Records Management or in related function, Masters preferred
• Demonstrated fluency in documentation impact assessment and needs analyses, and the development, hierarchy structure, and management of a range of documentation (Standards, SOPs, work instructions, job aids, guidance, training materials) with consideration for applicable regulatory requirements
• Deep expertise in Document Control and Management, technical writing principles, performance consultation, and emerging technologies (AI, machine learning, automation) in alignment with regulatory requirements and inspection readiness
• Experience working with and supporting Biologics and Device, Cell and Gene Therapies, Clinical, and Manufacturing, preferred
• Demonstrated project management expertise, lean methodologies
• Demonstrated leadership skills and experience managing cross-functional teams
• Direct experience with implementation of supportive learning technology and tools; learning management systems, augmented/virtual reality, training assignment automation
• Subject matter expertise in quality systems, documentation and records management, document development and structure
• Proficient experience with Microsoft Office Suite, Document Management System and Learning Management System; Specific system experience preferred Veeva, DocCompliance, and Cornerstone
• Demonstrated understanding GxP Training standards preferred.

Benefits

• Compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
• 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.
• This role will be eligible for overtime pay, in accordance with federal and state requirements.