Nivagen Pharmaceuticals, Inc. · 17 hours ago
Director of Quality Control
Sacramento, CA
Full-time
Onsite
Director/Executive
$120K/yr - $140K/yr
10+ years expNivagen Pharmaceuticals, Inc. 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. 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.
ManufacturingMarket ResearchPharmaceutical
Responsibilities
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
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
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
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
Oversee design, execution, and monitoring of stability studies in compliance with ICH guidelines
Ensure timely stability testing and trend analysis to support expiry dating, regulatory filings, and ongoing product quality review
Develop, track, and report quality metrics (e.g., OOS rate, lab investigation cycle time, test turnaround time, EM trends)
Drive continuous improvement initiatives such as Lean lab practices, automation, and digitalization
Optimize laboratory workflows for efficiency while maintaining compliance and data integrity
Act 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
Qualification
Required
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 (Approx 40 miles' radius)
Preferred
Master's or PhD in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or related discipline
A bachelor's degree with extensive experience may be considered
10+ years of experience in QC within pharmaceutical or biopharmaceutical manufacturing
5+ years of leadership/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
Benefits
Yearly bonus eligibility
Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being (Medical, dental, and vision coverage)
Paid time off plan
401 (k) savings plan
Company
Nivagen Pharmaceuticals, Inc.
Nivagen is engaged in the development, acquisition and sales of generic prescription drugs and over the counter products for the North American market.
11-50 employees
H1B Sponsorship
Nivagen Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (19)
2023 (15)
2022 (5)
2021 (11)
2020 (7)
Funding
Current Stage
Early StageTotal Funding
$31MKey Investors
Telegraph Hill Partners
2026-01-06Acquired
2023-08-09Series Unknown· $5M
2020-05-19Series Unknown· $16M
Recent News
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-07
2025-05-23
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