Master's or PhD in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or related discipline preferred.
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.
Responsibilities
Provide strategic leadership for QC teams, ensuring compliance and performance.
Direct day-to-day QC operations to support manufacturing schedules.
Ensure all QC activities comply with cGMP, FDA/EMA/ICH guidelines, and company SOPs.
Oversee method validation and implementation of new analytical technologies.
Manage stability studies and perform trend analysis for product quality.
Benefits
Competitive salary range.
Yearly bonus eligibility.
Comprehensive medical, dental, and vision coverage.
Paid time off plan.
401(k) savings plan.
Full Job Description
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: Vice President, QA
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 $200-245K Annually; Based on Experience
Yearly bonus eligibility
Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being (Medical, dental, and vision coverage)
