eQMS DocX Product Lead for Quality & Compliance

GuruNanda LLC; Buena Park (CA); On-site; USD 140,000 - 170,000; Full time

Job summary

Gurunanda LLC in Buena Park, CA seeks a QMS Document Control (DocX) System Product Manager to own the strategy and continuous improvement of the electronic document control platform. You will bridge Quality, IT, Manufacturing, and Operations to translate cGMP and data integrity requirements into a scalable solution for SOPs, forms, policies, and controlled docs in a sterile manufacturing environment.

The ideal candidate will manage system strategy, vendor decisions, rollout, training, adoption,

Qualifications

• 5+ years in product management within an FDA-regulated environment.
• Experience implementing or managing an eQMS Document Control system such as TrackWise, Veeva Quality, MasterControl, or ETQ Reliance.
• Strong understanding of 21 CFR Part 11 and ALCOA+ data integrity principles.

Responsibilities

• Own product roadmap for the electronic document control system.
• Lead eQMS implementation, configuration, and administration.
• Define compliant document lifecycle workflows (creation, review, approval, distribution).
• Collaborate with QA, Manufacturing, Regulatory Affairs, IT, and Operations.
• Lead training, change management, and user adoption activities.
• Provide metrics and insights to leadership to drive improvements.

Skills

Product management

Quality systems

QA/IT systems

eQMS administration

Digital quality transformation

Regulatory compliance

Education

Bachelor's degree in Life Sciences, Engineering, Information Systems, Quality

Tools

TrackWise

Veeva Quality

MasterControl

ETQ Reliance

Job description

Gurunanda LLC in Buena Park, CA seeks a QMS Document Control (DocX) System Product Manager to own the strategy and continuous improvement of the electronic document control platform. You will bridge Quality, IT, Manufacturing, and Operations to translate cGMP and data integrity requirements into a scalable solution for SOPs, forms, policies, and controlled docs in a sterile manufacturing environment.

The ideal candidate will manage system strategy, vendor decisions, rollout, training, adoption,