Director of Quality Control
Company: Nivagen Pharmaceuticals
Location: Sacramento
Posted on: February 16, 2026
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Job Description:
Job Description Job Description 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 Inc., 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 ICH guidelines. Ensure timely
stability testing and trend analysis to support expiry dating,
regulatory filings, and ongoing product quality review. Quality
Metrics & Continuous Improvement 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. Cross-Functional
Collaboration 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. Qualifications : Education/Experience: Master's
or PhD in Chemistry, Biochemistry, Microbiology, Pharmaceutical
Sciences, or related discipline preferred. 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.
Knowledge, Skills, and Abilities: 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. Requirements: Must live or be willing to move to
the Sacramento Metropolitan Region (Approx 40 miles' radius)
Benefits: Pay range: Competitive Salary Range 120k - 140k Annually
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 Additional Information: Nivagen to afford equal opportunity
for employment to all individuals regardless of race, color, age,
national origin, physical or mental disability, history of
disability, ancestry, citizenship status, political affiliation,
religion, gender, transgender, gender identity, marital status,
status as a parent, sexual orientation, veteran status, genetic
information or other factors prohibited by law, and to prohibit
harassment or retaliation based on any of these factors.
Keywords: Nivagen Pharmaceuticals, Yuba City , Director of Quality Control, Science, Research & Development , Sacramento, California
