Director of Quality Control

Director of Quality Control

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.

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.