Senior QA/QMS Deviations & Investigations Lead

Nivagenpharmaceuticals; Sacramento (CA); On-site; USD 80,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Career growth

Job summary

Nivagen Pharmaceuticals Inc. is seeking a QA/QMS Senior Specialist - Deviations & Investigations to lead deviation management across sterile GMP operations.

You will initiate, investigate, perform root-cause analysis, and close deviations per FDA/cGMP requirements, serving as the central contact for deviation lifecycle management. The role requires strong investigative writing, track record in sterile manufacturing, and cross-functional coordination with Manufacturing, QC, Engineering and

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, Microbiology, Engineering, or related field.
• 7–10 years in QA with deviation investigations in sterile pharmaceutical manufacturing.
• Expertise in RCA tools (Ishikawa, 5-Why, FMEA, fault tree).
• Experience investigating sterile deviations including media fill failures and environmental monitoring.
• Proficiency with TrackWise or Veeva QMS.

Responsibilities

• Own deviation lifecycle from initiation to closure within timelines.
• Act as primary contact for deviation activities across Manufacturing, QC, Engineering, and Validation.
• Conduct root cause analyses using Ishikawa, 5-Why, and fault tree methods.
• Author investigation narratives, IQAs, and deviation reports in TrackWise.
• Classify deviations by severity and assess impact on quality and compliance.
• Coordinate batch disposition with QA release and QC labs.
• Identify recurring deviations and escalate to CAPA.
• Track deviation KPIs and report trends during management reviews.
• Support internal audits and FDA inspections with records and summaries.
• Ensure deviations comply with ALCOA+ and 21 CFR Part 11.

Skills

Root cause analysis

FDA/cGMP compliance

Technical writing

Cross-functional collaboration

Data integrity

Education

Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, Microbiology, Engineering, or related field

Tools

TrackWise

Veeva QMS

Job description

Nivagen Pharmaceuticals Inc. is seeking a QA/QMS Senior Specialist - Deviations & Investigations to lead deviation management across sterile GMP operations.

You will initiate, investigate, perform root-cause analysis, and close deviations per FDA/cGMP requirements, serving as the central contact for deviation lifecycle management. The role requires strong investigative writing, track record in sterile manufacturing, and cross-functional coordination with Manufacturing, QC, Engineering and