QMS Document Control; DocX System Product Manager

Gurunanda is a fast-growing consumer wellness company committed to delivering high-quality products through innovation, operational excellence, and a strong commitment to quality and compliance.

As we continue to scale our manufacturing operations, we are investing in robust digital quality systems that support regulatory compliance, operational efficiency, and continuous improvement.

Gurunanda is a fast-growing consumer wellness company committed to delivering high-quality products through innovation, operational excellence, and a strong commitment to quality and compliance.

As we continue to scale our manufacturing operations, we are investing in robust digital quality systems that support regulatory compliance, operational efficiency, and continuous improvement.

Gurunanda is seeking a QMS Document Control (DocX) System Product Manager to own the strategy, implementation, and continuous improvement of our electronic Quality Management System (eQMS) Document Control platform
.

This role sits at the intersection of Quality, IT, Manufacturing, and Operations
, translating cGMP, 503B, and data integrity requirements into a scalable, user-friendly document management solution that supports SOPs, work instructions, forms, policies, and controlled documentation across a sterile manufacturing environment.

The ideal candidate will serve as the product owner for the DocX platform
, managing the full lifecycle — from system strategy, requirements gathering, vendor/platform decisions, configuration, rollout, training, adoption, and continuous improvement.

This is a highly cross-functional role requiring a strong understanding of quality systems, regulatory compliance, document control processes, and technology implementation.

• Own the product roadmap for the electronic document control system, prioritizing enhancements, fixes, and improvements based on:
• Compliance requirements
• Audit readiness
• User feedback
• Business needs
• Define product vision, priorities, and implementation strategies for the DocX platform.
• Drive continuous improvement initiatives to enhance system usability, compliance, and operational efficiency.

• Lead selection, configuration, and administration of the eQMS Document Control module (such as Track Wise or equivalent platforms).
• Manage:
• Workflow configuration
• System requirements
• Data migration
• User roles and permissions
• System integrations
• Support integration with other Quality Management System modules including:
• Change Control
• Deviations
• CAPA
• Training Management
• Partner with IT and vendors to troubleshoot issues and implement system improvements.

• Define and maintain compliant document lifecycle workflows, including:
• Document creation
• Review
• Approval
• Distribution
• Periodic review
• Revision control
• Retirement/archival
• Ensure compliance with:
• FDA cGMP requirements
• 21 CFR Part 11
• ALCOA+ data integrity principles
• 503B regulatory expectations
• Establish secure document repositories with appropriate:
• Retention policies
• Access controls
• Archiving processes
• Audit trails

• Partner with Quality Assurance, Manufacturing, Regulatory Affairs, IT, and Operations teams to:
• Gather requirements
• Translate business needs into system specifications
• Develop process documentation
• Create training materials
• Act as the bridge between technical teams and quality stakeholders.
• Facilitate alignment between users, leadership, and system vendors.

• Lead system rollout activities including:
• User acceptance testing (UAT)
• Training development
• User adoption initiatives
• Change management activities
• Support system upgrades, enhancements, and new feature releases.
• Ensure users are effectively trained on document control processes and system functionality.

• Define and track DocX system performance metrics, including:
• Document approval cycle time
• Overdue document reviews
• User adoption
• Workflow efficiency
• Audit readiness metrics
• Provide reporting and recommendations to site leadership and senior management.
• Identify improvement opportunities based on:
• User feedback
• Audit observations
• Regulatory changes
• Operational needs

• Ensure document control systems and records remain continuously audit-ready.
• Support preparation for FDA and regulatory inspections related to document management.
• Assist with responses and documentation requests during inspections.

• Bachelor's degree in Life Sciences, Engineering, Information Systems, Quality, or a related field (or equivalent experience).
• 5+ years of experience in:
• Product management
• Quality systems
• QA/IT systems
• eQMS administration
• Digital quality transformation
• Experience working within an FDA-regulated environment required.
• Experience in sterile injectable manufacturing, cGMP, or 503B operations strongly preferred.
• Hands-on experience…