GMP Document Control & Training Manager

Nivagen Pharmaceuticals; Sacramento (CA); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

Job summary

Nivagen Pharmaceuticals, a Sacramento-based global generic medications company, is seeking a Document Control & Training Manager to lead document control and GMP training across quality and manufacturing operations. This hands-on leadership role requires building scalable systems compliant with FDA/cGMP and ICH requirements.

The ideal candidate will oversee SOP lifecycle, ensure audit-ready training records, and drive KPI tracking for document and training programs while collaborating with QMS

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, Engineering, or a related field.
• 7–10 years of QA and document control/training management in sterile pharmaceutical manufacturing.
• Experience with 21 CFR Parts 210, 211, 212; ICH Q7 and Q10; FDA expectations for controlled documents.
• Proficiency with electronic document management systems (eInfotree, TrackWise or similar).
• Experience leading GMP training programs for sterile/aseptic operations.

Responsibilities

• Lead and manage the document control team, including supervision of specialists and coordinators.
• Own the SOP lifecycle from drafting through review, approval, issuance, review, and retirement.
• Maintain the controlled document hierarchy in compliance with 21 CFR Part 211 and ICH Q10.
• Manage the eDMS, including access, workflows, version control, and archival.
• Develop and manage site-wide cGMP training, including new hire orientation and retraining.
• Ensure training records are audit-ready and maintain training matrices for GMP personnel.
• Lead SOP Harmonization across departments and track KPIs like revision cycles and backlog.

Job description

Nivagen Pharmaceuticals, a Sacramento-based global generic medications company, is seeking a Document Control & Training Manager to lead document control and GMP training across quality and manufacturing operations. This hands-on leadership role requires building scalable systems compliant with FDA/cGMP and ICH requirements.

The ideal candidate will oversee SOP lifecycle, ensure audit-ready training records, and drive KPI tracking for document and training programs while collaborating with QMS