Director of Quality Control

Director of Quality Control

Location: Greater Sacramento Area (Onsite)

Compensation: $150,000 - $200,000 DOE + Discretionary Performance Bonus + Comprehensive Benefits

Position Summary

A growing, highly regulated life sciences manufacturing organization is seeking an experienced Director of Quality Control to provide strategic leadership for its Quality Control function. Reporting to executive leadership, this individual will oversee laboratory operations, analytical testing, regulatory compliance, quality systems, and continuous improvement while ensuring timely support of commercial manufacturing operations.

This is a highly visible leadership opportunity for an individual with a proven track record of building high-performing laboratory organizations, maintaining inspection readiness, and establishing robust quality systems within a GMP-regulated manufacturing environment.

Key Responsibilities

Quality Control Leadership

• Develop and execute the laboratory strategy, departmental objectives, operational plans, KPIs, and annual budget.
• Build and lead a high-performing Quality Control organization focused on scientific excellence, compliance, and continuous improvement.
• Serve as the Quality Control representative with executive leadership, providing performance metrics, risk assessments, and operational updates.
• Mentor and develop laboratory personnel while fostering employee engagement and succession planning.

Laboratory Operations & Regulatory Compliance

• Ensure laboratory operations remain compliant with applicable FDA, cGMP, ICH, USP, and other regulatory requirements.
• Maintain a constant state of inspection readiness and lead regulatory inspections, customer audits, and third-party assessments.
• Develop and maintain laboratory procedures, specifications, testing protocols, and quality documentation.
• Monitor evolving regulatory expectations and implement improvements to laboratory systems and compliance programs.
• Ensure laboratory safety, environmental compliance, and good documentation practices throughout all operations.

Analytical Testing & Laboratory Management

• Oversee analytical testing for raw materials, in-process materials, finished products, environmental monitoring, stability studies, and validation activities.
• Ensure accurate, timely, and compliant laboratory testing to support manufacturing schedules and product release.
• Provide oversight for analytical method development, validation, transfer, qualification, and lifecycle management.
• Direct laboratory instrumentation programs including qualification, calibration, maintenance, and performance monitoring.
• Review and approve analytical data, laboratory reports, specifications, validation documentation, and Certificates of Analysis.

Quality Systems & Investigations

• Lead investigations involving laboratory deviations, out-of-specification (OOS), out-of-trend (OOT), and atypical results.
• Drive root cause analysis, corrective and preventive actions (CAPAs), and continuous process improvements.
• Oversee laboratory-related change controls, documentation, electronic records, and data integrity initiatives.
• Partner closely with Quality Assurance to support batch disposition and regulatory compliance.
• Ensure effective management of stability programs, reference standards, and retained sample programs.

Manufacturing & Cross-Functional Support

• Collaborate with Manufacturing, Engineering, Supply Chain, Technical Operations, Validation, and Quality Assurance to support commercial production activities.
• Provide laboratory expertise for process improvements, validation efforts, technology transfers, and new product introductions.
• Support supplier qualification activities and external laboratory relationships.
• Partner with cross-functional teams to ensure quality objectives align with operational goals.

Continuous Improvement

• Develop laboratory performance metrics and monitor trends to improve efficiency, compliance, and quality.
• Lead initiatives that optimize laboratory operations, automate workflows, and improve overall performance.
• Evaluate new technologies, laboratory systems, and best practices that support long-term organizational growth.
• Promote a culture of operational excellence, scientific rigor, and continuous improvement.

Qualifications

Required

• Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, Biology, Engineering, or another related scientific discipline. Ph.D. preferred.
• Minimum of 8 years of progressive Quality Control experience within a regulated pharmaceutical, biotechnology, or life sciences manufacturing environment.
• Minimum of 5 years of leadership experience managing Quality Control laboratory operations.
• Extensive knowledge of FDA regulations, cGMP requirements, ICH guidelines, USP standards, laboratory quality systems, and data integrity principles.
• Demonstrated experience leading regulatory inspections, customer audits, and laboratory quality improvement initiatives.
• Strong experience with laboratory investigations, CAPAs, analytical method validation, laboratory instrumentation, and quality documentation.
• Excellent leadership, communication, organizational, and problem-solving skills.

Preferred

• Experience supporting laboratory start-up, expansion, or significant quality system implementations.
• Experience implementing or optimizing LIMS, chromatography data systems, or other laboratory technologies.
• Demonstrated success building and developing high-performing laboratory teams.

What You'll Bring

• Strategic leadership with a collaborative, hands-on management style.
• Strong business acumen and the ability to influence cross-functional stakeholders.
• Passion for developing high-performing teams and building a culture of scientific excellence.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Commitment to maintaining the highest standards of product quality, regulatory compliance, and operational excellence.