Senior Manager, GxP Strategic Document Partner

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Manager, GxP Strategic Document Partner in United States.

This role sits at the intersection of quality, compliance, and process architecture, offering a unique opportunity to shape how critical documentation supports global operations. You will act as a strategic partner to quality and business leaders, ensuring that documentation frameworks are not only compliant but also efficient, scalable, and inspection-ready. Working in a highly regulated environment, you will drive innovation by leveraging digital tools and modern documentation strategies. The position involves close collaboration with cross-functional teams to align documentation with end-to-end processes and training systems. With a strong focus on continuous improvement, you will play a key role in enhancing quality systems and reducing complexity. This is an ideal opportunity for a seasoned professional who thrives in strategic, high-impact roles within GxP-regulated environments.

• Serve as a strategic partner for assigned functions or quality systems, aligning documentation and records management with regulatory, quality, and business objectives.
• Design and oversee process documentation architecture for the global Quality Management System, ensuring clarity, integration, and inspection readiness.
• Conduct document impact and needs analyses to optimize documentation structures and reduce redundancy.
• Collaborate with Quality System Owners, Process Owners, and digital teams to ensure documentation reflects end-to-end processes and integrates with training and systems.
• Lead and support global documentation initiatives, ensuring consistent standards and best practices across the organization.
• Drive innovation by leveraging digital tools, automation, and emerging technologies such as AI and machine learning.
• Monitor and evaluate documentation system performance using metrics to ensure compliance and effectiveness.
• Act as an escalation point for document-related challenges, providing strategic solutions and ensuring operational continuity.
• Partner with training and continuous improvement teams to enhance documentation processes and ensure alignment with GxP training requirements.

Requirements:

• Bachelor’s degree with 5–10 years of experience in GxP document and records management or a related field; advanced degree preferred.
• Strong expertise in document control, documentation architecture, and regulatory-compliant content development (e.g., SOPs, standards, training materials).
• Proven experience conducting documentation impact assessments and managing complex document hierarchies.
• Solid understanding of quality systems and regulatory requirements in GxP environments.
• Experience in project management and process improvement methodologies (e.g., Lean).
• Familiarity with digital tools, document management systems, and learning management systems (e.g., Veeva, DocCompliance, Cornerstone).
• Demonstrated ability to lead cross-functional initiatives and influence stakeholders at multiple levels.
• Knowledge of emerging technologies (AI, automation) applied to documentation and process optimization.
• Excellent communication, analytical, and problem-solving skills.

Benefits:

• Competitive hourly compensation ($75–$80/hour) with eligibility for overtime pay.
• Opportunity to work on high-impact projects within a regulated and innovative environment.
• Exposure to advanced technologies and digital transformation initiatives.
• Flexible work arrangements depending on assignment structure.
• Comprehensive benefits package provided by the employment partner.
• Collaborative and cross-functional work environment with strong professional growth opportunities.