Head of Quality Control - Pharma Manufacturing & Compliance

Nivagen Pharmaceuticals, Inc.; Sacramento (CA); Presencial; USD 200.000 - 245.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Yearly bonus eligibility

Medical, dental, and vision coverage

Paid time off

Descripción de la vacante

Nivagen Pharmaceuticals, Sacramento, CA, is seeking a Director of Quality Control to lead all QC operations in a pharmaceutical manufacturing facility. You will oversee chemistry, microbiology, stability, and raw materials testing, ensuring data integrity and regulatory compliance to support timely product release.

We seek a leader with 10+ years in QC, 5+ years in GMP lab management, and strong expertise in analytical chemistry or microbiology, plus experience with LIMS/ELN systems and method

Formación

• Advanced degree in a relevant science and 10+ years in QC within pharma/biopharma manufacturing.
• Proven leadership in GMP laboratory settings with 5+ years managing teams.
• Experience preparing for FDA/EMA inspections and regulatory audits.
• Strong background in analytical chemistry and/or microbiology; method validation expertise.

Responsabilidades

• Lead QC operations across chemistry, microbiology, stability, raw materials.
• Develop and mentor QC managers, supervisors, and analysts to ensure capability and compliance.
• Ensure on-time testing and release to support manufacturing schedules.
• Maintain cGMP, data integrity, and regulatory compliance across laboratory activities.
• Drive continuous improvement and QC automation, Lean lab practices, and digitalization.
• Support regulatory submissions by providing QC data and responses to agency questions.

Conocimientos

Leadership

Regulatory knowledge

Quality systems

Data integrity

Cross-functional collaboration

Educación

Master's or PhD in Chemistry/Biochemistry/Microbiology/Pharmaceutical Sciences

Bachelor's degree with extensive experience

Herramientas

LIMS

ELN

Descripción del empleo

Nivagen Pharmaceuticals, Sacramento, CA, is seeking a Director of Quality Control to lead all QC operations in a pharmaceutical manufacturing facility. You will oversee chemistry, microbiology, stability, and raw materials testing, ensuring data integrity and regulatory compliance to support timely product release.

We seek a leader with 10+ years in QC, 5+ years in GMP lab management, and strong expertise in analytical chemistry or microbiology, plus experience with LIMS/ELN systems and method