Director of Quality Control

About the Company:

Nivagen is a global company devoted to improving lives by developing high-quality, affordable generic prescription drugs and over-the-counter products for the North American market. For over a decade, we have remained committed to our core values of excellence, integrity, and respect for people. Our dedicated team works collaboratively to advance manufacturing, distribution, and quality control, taking a comprehensive approach to healthcare. Through vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and an unwavering focus on excellence, we continually strive to enhance medication accessibility and affordability.

We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and strong training and development programs. By investing in our workforce and nurturing a culture of growth and support, we empower our team to drive innovation and make a positive impact in healthcare. Our mission at Nivagen is clear: to improve lives by providing high-quality, affordable medications while upholding the highest standards of integrity and excellence.

As a leader in pharmaceutical manufacturing, Nivagen is committed to producing sterile products that meet the healthcare industry’s rigorous demands. Specializing in the production of vials, pre-filled syringes (PFS), and IV bags, we aim to make a meaningful impact on patient care. Join our team to help push the boundaries of sterile manufacturing, achieving the highest standards in safety, quality, and operational efficiency.

Job Location:

Nivagen Pharmaceuticals, Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

About the Job:

Title of the Position: Director of Quality Control

Department: Quality Control

Reports to: Head of Quality

The Director of Quality Control leads all QC operations within a pharmaceutical manufacturing facility, ensuring reliable, compliant testing that meets regulatory expectations and supports timely product release. This role oversees QC laboratories (chemistry, microbiology, analytical development support, raw materials, stability, and in-process testing), manages scientific and operational strategy, drives continuous improvement, and ensures data integrity and regulatory compliance across all laboratory activities.

Responsibilities:

• Leadership & Management

  • Provide strategic leadership for QC teams, including chemistry, microbiology, stability, and raw materials testing.
  • Develop and mentor QC managers, supervisors, and analysts to ensure strong technical capability and compliance culture.
  • Establish resource plans, staffing, skills development, and succession planning.
  • Set performance expectations, conduct performance reviews, and manage career development.

  Laboratory Operations & Oversight

  • Direct day-to-day QC operations to support manufacturing schedules, ensuring on-time testing and release.
  • Oversee testing for raw materials, in-process samples, finished products, environmental monitoring, and stability programs.
  • Ensure proper functioning, maintenance, and qualification/calibration of all lab equipment.
  • Oversee sample management, laboratory workflows, and prioritization.
  • Implement robust OOS/OOT/OOE processes and drive investigations to scientifically sound conclusions.

  Regulatory Compliance & Quality Systems

  • Ensure all QC activities comply with cGMP, FDA/EMA/ICH guidelines, USP/EP/JV standards, and company SOPs.
  • Own and maintain quality systems related to laboratory operations, including:
  • Change control
  • Deviations and investigations
  • CAPA management
  • Document control
  • Data integrity program
  • Prepare for and lead QC aspects of regulatory inspections and internal/external audits.
  • Ensure laboratory data integrity practices meet ALCOA+ principles.

  Analytical Strategy & Method Management

  • Oversee method validation, verification, transfer, and lifecycle management activities.
  • Evaluate and implement new analytical technologies to improve QC reliability, efficiency, and scientific rigor.
  • Collaborate with R&D/Analytical Development to ensure smooth tech transfer of analytical methods and specifications.
  • Ensure the QC team supports process changes, comparability studies, and product lifecycle management.

  Stability Program Management

  • Oversee design, execution, and monitoring of stability studies in compliance with I