GMP Document Control & Training Manager

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

Benefits offered by this job

Medical, dental, and vision coverage

Paid time off

Job summary

Nivagen Pharmaceuticals, Inc. is seeking a Document Control & Training Manager to lead the document control and GMP training programs across quality and manufacturing operations in a sterile pharmaceutical setting.

The role oversees SOP lifecycle, regulatory compliance of controlled documents, and supervision of Document Control Specialists and Training Coordinators. A hands‑on leader is preferred to build scalable systems and ensure FDA readiness.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Pharmacy, Engineering, or related field.
• 7–10 years of QA experience managing document control and training in sterile pharmaceutical manufacturing; 2+ years in supervision.
• Strong knowledge of 21 CFR Parts 210, 211, 212; ICH Q7/Q10; FDA expectations for controlled docs and training systems.

Responsibilities

• Lead the document control team and supervise staff.
• Own the SOP lifecycle from drafting to retirement across GMP departments.
• Maintain controlled document hierarchy per 21 CFR Part 211 and ICH Q10.
• Manage electronic document system, workflows, access, version control, archiving.
• Develop and manage site-wide cGMP training programs, new hire orientation, and retraining.
• Maintain training records and matrices for GMP personnel.
• Lead SOP Harmonization across multiple functions.
• Track KPIs: SOP revision time, overdue training, completion, backlog.
• Support audits and FDA inspections with records and reports.
• Collaborate with QMS on quality council and improvements.

Skills

Document control

Training programs

GMP

SOP drafting

Regulatory compliance

eInfotree/TrackWise

Gowning qualification

Aseptic technique

Project management

Communication skills

Education

BSc in Life Sciences / Pharma

7–10 years QA/Document control experience

2+ years supervisory experience

Tools

eInfotree

TrackWise

LMS

Microsoft Office

Job description

Nivagen Pharmaceuticals, Inc. is seeking a Document Control & Training Manager to lead the document control and GMP training programs across quality and manufacturing operations in a sterile pharmaceutical setting.

The role oversees SOP lifecycle, regulatory compliance of controlled documents, and supervision of Document Control Specialists and Training Coordinators. A hands‑on leader is preferred to build scalable systems and ensure FDA readiness.