Director of Quality Control – Pharma Manufacturing Leader

Nivagen Pharmaceuticals; Sacramento (CA); On-site; USD 200,000 - 245,000; Full time

Benefits offered by this job

Yearly bonus eligibility

Benefits

Paid time off plan

Job summary

Nivagen Pharmaceuticals in Sacramento, CA, is seeking a Director of Quality Control to lead QC operations within our pharmaceutical manufacturing facility, ensuring compliant testing and timely product release.

You will oversee laboratories (chemistry, microbiology, analytical development support, raw materials, stability, in-process testing), manage strategy, drive improvements, and ensure data integrity for regulatory compliance.

Qualifications

• Master’s or PhD in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or related discipline preferred.
• Bachelor’s degree with extensive experience may be considered.
• 10+ years of QC experience in pharma/biopharma manufacturing.
• 5+ years of leadership/management in a GMP laboratory setting.
• Experience preparing for FDA, EMA inspections.

Responsibilities

• Provide strategic leadership for QC teams across chemistry, microbiology, stability, and raw materials testing.
• Direct day-to-day QC operations to support manufacturing schedules and on-time release.
• Oversee regulatory compliance and quality systems including CAPA, change control, deviations.
• Lead method validation, transfer, and lifecycle management with R&D.
• Drive continuous improvement and data integrity across QC activities.

Skills

Leadership

Regulatory acumen

Analytical thinking

Communication

Education

Master’s or PhD in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or related discipline preferred.

Bachelor’s degree with extensive experience may be considered

10+ years of QC experience in pharma/biopharma manufacturing

5+ years of leadership/management in GMP lab setting

Experience preparing for FDA, EMA inspections

Tools

LIMS/ELN

Job description

Nivagen Pharmaceuticals in Sacramento, CA, is seeking a Director of Quality Control to lead QC operations within our pharmaceutical manufacturing facility, ensuring compliant testing and timely product release.

You will oversee laboratories (chemistry, microbiology, analytical development support, raw materials, stability, in-process testing), manage strategy, drive improvements, and ensure data integrity for regulatory compliance.