Director of Quality Control

Nivagen Pharmaceuticals•Sacramento, CA

9d•$200,000 - $245,000•Onsite

About The Position

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. The role oversees QC laboratories and programs covering 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 laboratory activities. The Director provides strategic leadership and develops QC teams, directs daily laboratory operations, owns laboratory-related quality systems, and prepares for and leads QC aspects of regulatory inspections and audits. The role oversees analytical method management and stability programs, develops quality metrics, improves laboratory workflows, and collaborates with QA, Manufacturing, Regulatory Affairs, Supply Chain, and R&D. The position is based at Nivagen Pharmaceuticals in Sacramento, California, and reports to the Vice President, QA. Candidates must live or be willing to move to the Sacramento Metropolitan Region, approximately a 40-mile radius.

Requirements

At least 10 years of QC experience in pharmaceutical or biopharmaceutical manufacturing.
At least 5 years of leadership or management experience in a GMP laboratory setting.
Experience preparing for and hosting inspections by FDA, EMA, or other health authorities.
Strong background in analytical chemistry and/or microbiology.
Experience with method validation, QC automation, LIMS/ELN, and electronic data management systems.
Deep knowledge of cGMP, ICH guidelines, USP/EP, and regulatory expectations.
Strong scientific judgment and technical problem-solving skills.
Excellent leadership, communication, and interpersonal skills.
Ability to manage multiple priorities and drive timely execution.
Demonstrated ability to develop high-performing teams and a culture of quality and compliance.
Must live or be willing to move to the Sacramento Metropolitan Region (approximately a 40-mile radius).

Nice To Haves

Master’s or PhD in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or a related discipline.
A bachelor’s degree with extensive experience may be considered.

Responsibilities

Provide strategic leadership for QC teams, including chemistry, microbiology, stability, and raw materials testing.
Develop and mentor QC managers, supervisors, and analysts; establish resource plans, staffing, skills development, and succession planning; set performance expectations; conduct performance reviews; and manage career development.
Direct day-to-day QC operations to support manufacturing schedules and on-time testing and product release.
Oversee testing for raw materials, in-process samples, finished products, environmental monitoring, and stability programs.
Ensure proper functioning, maintenance, and qualification or calibration of laboratory equipment; oversee sample management, laboratory workflows, and prioritization.
Implement robust OOS/OOT/OOE processes and drive investigations to scientifically sound conclusions.
Ensure QC activities comply with cGMP, FDA/EMA/ICH guidelines, USP/EP/JV standards, and company SOPs.
Own and maintain laboratory quality systems, including change control, deviations and investigations, CAPA management, document control, and the data integrity program.
Prepare for and lead QC aspects of regulatory inspections and internal and external audits; ensure laboratory data integrity practices meet ALCOA+ principles.
Oversee analytical method validation, verification, transfer, and lifecycle management.
Evaluate and implement analytical technologies to improve QC reliability, efficiency, and scientific rigor; collaborate with R&D/Analytical Development on analytical method and specification tech transfer.
Ensure QC supports process changes, comparability studies, and product lifecycle management.
Oversee the design, execution, and monitoring of stability studies in compliance with ICH guidelines; ensure timely testing and trend analysis supporting expiry dating, regulatory filings, and ongoing product quality review.
Develop, track, and report quality metrics, including OOS rate, laboratory investigation cycle time, test turnaround time, and environmental monitoring trends.
Drive continuous improvement initiatives such as Lean lab practices, automation, and digitalization; optimize laboratory workflows while maintaining compliance and data integrity.
Serve as a QC subject matter expert in cross-functional teams, including QA, Manufacturing, Regulatory Affairs, Supply Chain, and R&D.
Participate in material/vendor qualification, change control reviews, and deviation boards.
Support regulatory submissions by providing QC data, summary reports, and responses to agency questions.