QMS Document Control (DocX) System Product Manager in Cypress, California

QMS Document Control (DocX) System Product Manager

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.

Key Responsibilities

• Product Ownership & Roadmap Management
• Own the product roadmap for the electronic document control system, prioritizing enhancements, fixes, and improvements based on compliance requirements, audit readiness, user feedback, and 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.

• eQMS Implementation & System Administration
• 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.

• Document Control & Regulatory Compliance
• 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.

• Cross-Functional Collaboration
• 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.

• Implementation, Training & Change Management
• 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.

• Metrics, Reporting & Continuous Improvement
• 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.

• Inspection Readiness & Compliance Support
• 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.

Required Qualifications & Experience

• 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 implementing or managing an eQMS Document Control system such as Track Wise, Veeva Quality, Master Control, ETQ Reliance, similar platforms.
• Experience with workflow configuration, system validation, document migration, user permissions, system rollout.
• Strong understanding of 21 CFR Part 11, ALCOA+ data integrity principles, GMP document control practices.
• Proven ability to gather requirements and translate them into system designs, functional specifications, process documentation.
• Experience defining system KPIs and presenting insights to leadership.
• Strong project management skills with the ability to independently manage complex initiatives.
• Excellent…