Director of Quality

DIRECTOR OF QUALITY

Kelly® Science & Clinical is seeking a Director of Quality for a direct-hire, full-time, onsite position with the Client at their Irvine, California facility. If you’re passionate about building and leading robust Quality systems in a GMP-regulated pharmaceutical environment and are ready to take the next step in your career, trust the experts at Hiring Experts.

Salary Range: $135,000 – $160,000 depending on experience

Schedule: Mon-Fri Onsite

Overview

The Client is a pharmaceutical manufacturing organization committed to delivering high-quality, compliant products that meet all regulatory and customer requirements. The Director of Quality will oversee the Quality Assurance and Quality Control functions at the Irvine facility, ensuring all products are manufactured consistently and in compliance with cGMPs and applicable regulatory standards.

This role is responsible for strategic leadership of site Quality Systems, regulatory inspection readiness, continuous improvement initiatives, and cross-functional collaboration to support manufacturing, R&D, and clinical operations.

Responsibilities:

• Provide strategic oversight of all Quality Systems at the facility, ensuring products consistently meet quality and regulatory specifications.
• Plan and direct resources and activities of Quality Assurance functions, ensuring facility-wide compliance with applicable standards and regulations.
• Manage systems for raw material, product, and document review, including approvals and rejections.
• Oversee the Quality Control laboratory and laboratory compliance activities.
• Ensure cGMP requirements and quality standards are recognized, understood, and maintained across the facility.
• Assure facilities, utilities, and equipment systems meet cGMP requirements.
• Oversee investigations of deviations, OOS results, and non-conformances; chair site Material Review Boards.
• Establish raw material and finished product specifications in alignment with regulatory requirements, customer needs, and product development.
• Author and/or approve SOPs, protocols, qualifications, validations, and quality reports.
• Manage customer complaint and AER systems, including investigations, resolutions, and CAPA implementation.
• Ensure all employees are trained in cGMP requirements and quality policies.
• Participate actively in production, quality unit, and management meetings as required.
• Develop and maintain tracking methods for quality system performance and continuous improvement initiatives.
• Coordinate and manage vendor and supplier audits.
• Manage the Annual Product Review (APR) program and ensure Product Quality Reports are completed on time.
• Collect, analyze, and report Quality Key Performance Indicators (KPIs) in support of Management Review.
• Partner cross-functionally with manufacturing, R&D, clinical, and other disciplines to maintain inspection readiness.
• Serve as the primary interface for inspections by FDA, DEA, other regulatory agencies, and customers.
• Support oversight of document control and archival systems.
• Utilize statistical process control tools to monitor and evaluate quality trends.
• Develop, implement, and maintain quality agreements with customers and partners.
• Maintain budgetary and managerial responsibility for Quality Assurance and Quality Control departments at the facility.

Qualifications:

• Bachelor’s degree in a scientific discipline required.
• 12+ years of experience in a pharmaceutical GMP-regulated manufacturing environment with demonstrated progressive responsibility.
• 5+ years of people management experience, or an equivalent combination of education and experience.
• Strong commitment to quality, compliance, and continuous improvement with proven leadership capability.
• Ability to read, interpret, and apply technical procedures, SOPs, GMPs, and governmental regulations.
• Strong written and verbal communication skills.
• Demonstrated ability in leadership, staff development, motivation, and conflict resolution.
• Strong attention to detail with the ability to manage multiple priorities effectively.
• ASQC quality certifications, ISO 9000 knowledge, or formal audit training preferred.

What happens next:

Once you apply, you’ll proceed to the next steps if your skills and experience are a good match. Even if this position isn’t the right fit, you’ll remain part of our network—giving our team of expert Science & Clinical recruiters continued access to your profile and opening the door to future opportunities.