Director of Quality Assurance

Director of Quality Assurance

Location: Greater Sacramento Area, CA (Onsite)

Compensation: 175K to 225K, plus discretionary bonus

Position Summary

An established and growing pharmaceutical manufacturing organization is seeking an experienced Director of Quality Assurance to lead all quality functions for a state-of-the-art manufacturing facility. Reporting directly to executive leadership, this individual will provide strategic and operational oversight of Quality Assurance, ensuring regulatory compliance, inspection readiness, and continuous improvement across the organization.

This is a highly visible leadership opportunity for someone who thrives in a fast-paced manufacturing environment and has extensive experience building and maintaining quality systems, leading regulatory inspections, and developing high-performing quality teams.

Key Responsibilities

Quality Leadership

• Develop and execute the site's quality strategy, objectives, KPIs, and departmental budget.
• Foster a culture centered on quality, compliance, risk management, and continuous improvement.
• Provide executive leadership with quality metrics, compliance trends, and recommendations for process enhancements.
• Lead and mentor the Quality Assurance organization while driving employee development and succession planning.

Regulatory Compliance

• Ensure ongoing compliance with FDA, cGMP, ICH, and other applicable domestic and international regulatory requirements.
• Serve as the primary Quality representative during regulatory agency inspections and customer audits.
• Oversee responses to audit observations, regulatory findings, and corrective action plans.
• Monitor regulatory changes and implement updates to quality systems and procedures as needed.

Quality Systems

• Provide oversight of the Quality Management System (QMS), including document control, deviations, CAPAs, change controls, investigations, validation documentation, and data integrity programs.
• Ensure effective management of controlled documentation throughout its lifecycle.
• Lead implementation and continuous improvement of electronic quality systems and document management processes.
• Maintain compliance with electronic records and data integrity requirements.

Manufacturing Quality Support

• Partner with Manufacturing, Engineering, Validation, Supply Chain, and Technical Operations to support commercial production activities.
• Review manufacturing records, investigations, validation activities, and quality documentation to support timely product release.
• Provide quality oversight for process improvements, technology transfers, validation activities, and operational changes.
• Support customer quality requirements and cross-functional quality initiatives.

Continuous Improvement

• Lead site-wide quality risk management initiatives.
• Monitor quality metrics and trend data to identify opportunities for improvement.
• Drive root cause investigations and ensure effective corrective and preventive actions.
• Conduct internal audits and self-inspections to maintain inspection readiness.

Qualifications

Required

• Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Engineering, Biology, or a related scientific discipline. Advanced degree preferred.
• 10+ years of progressive Quality Assurance experience within a regulated pharmaceutical, biotechnology, or life sciences manufacturing environment.
• Demonstrated leadership experience managing Quality Assurance teams.
• Thorough knowledge of FDA regulations, cGMP requirements, ICH guidelines, and quality systems.
• Experience leading successful regulatory inspections and customer audits.
• Strong knowledge of quality systems including CAPA, change control, deviations, investigations, document control, validation, and data integrity.
• Excellent communication, leadership, organizational, and problem-solving skills.

Preferred

• Experience supporting facility start-up, expansion, or major quality system implementations.
• Experience implementing electronic quality management systems (eQMS), LIMS, or related quality technologies.
• Proven ability to build and develop high-performing quality organizations.

What You'll Bring

• Strategic leadership with a hands-on management style.
• Strong business acumen and the ability to influence cross-functional teams.
• Passion for building quality culture while driving operational excellence.
• Ability to manage multiple priorities in a dynamic, fast-paced environment.
• Commitment to maintaining the highest standards of product quality, compliance, and patient safety.

Compensation & Benefits

• Competitive base salary
• Annual performance bonus
• Comprehensive medical, dental, vision, and retirement benefits
• Paid time off and holidays
• Opportunity to play a key leadership role within a growing manufacturing organization