Kelly® Science & Clinical is seeking a Director of Quality for a direct hire opportunity with one of our clients, a leading small molecule CDMO at their Irvine, CA facility. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Position Title: Director of Quality
Position Type: Direct hire
Workplace: Onsite in Irvine, CA
Salary Range: $135,000–$160,000 per year
Are you a skilled leader with a passion for quality and regulatory excellence in pharmaceutical manufacturing? A premier specialty CDMO is seeking an accomplished Director of Quality to lead Quality Assurance and Quality Control functions at our state-of-the-art facility in Irvine, CA.
Position Overview:
As the Director of Quality, you will be at the forefront of driving and maintaining the highest standards of product quality and regulatory compliance at our Irvine site. This critical leadership role ensures robust quality systems, fosters a culture of continuous improvement and regulatory readiness, and cultivates cross-functional collaboration to deliver outstanding results for partners and clients.
Key Responsibilities:
- Provide strategic direction and hands-on oversight to all Quality Assurance and Quality Control teams, ensuring robust compliance with cGMP, FDA, DEA, and other regulatory requirements.
- Lead the design, implementation, and continuous improvement of facility-wide quality systems, guaranteeing products consistently meet all quality specifications and client expectations.
- Direct quality-related activities pertaining to raw materials, in-process and finished products, including document control, batch review, disposition, and release.
- Oversee all operations of the Quality Control laboratory, ensuring the highest standards of data integrity, accuracy, and compliance.
- Lead thorough investigations of deviations, non-conformances, and OOS events, chairing the site's Material Review Board and driving effective CAPA programs.
- Develop product specifications aligned with regulatory requirements and customer expectations, collaborating closely with product development, manufacturing, and R&D teams.
- Author, review, and approve SOPs, qualification protocols, validation reports, and other critical documentation.
- Drive employee training initiatives to ensure widespread and consistent understanding of cGMP and quality standards across the organization.
- Analyze quality performance metrics and implement strategies for continual improvement; oversee timely completion of Annual Product Reviews and key quality reports.
- Manage external and internal audits, proactively guiding the facility toward inspection readiness and acting as the primary interface for regulatory bodies and client auditors.
- Leverage statistical process controls to monitor, analyze, and report quality trends.
- Develop and maintain quality agreements with key partners; manage customer complaint resolution programs.
- Oversee departmental budgets and resource planning, ensuring effective stewardship and operational excellence within the Quality departments.
Professional Qualifications:
- Bachelor’s degree in a scientific discipline (advanced degree preferred).
- Minimum 12 years of progressive experience in a cGMP-regulated pharmaceutical manufacturing environment, with significant leadership responsibility.
- At least 5 years in a management or supervisory capacity, demonstrating exceptional mentoring, motivation, and conflict resolution abilities.
- Deep knowledge of quality assurance, regulatory compliance, and inspection preparedness (FDA, DEA, etc.).
- Proficient in interpreting complex technical protocols, SOPs, and global regulatory standards.
- Excellent communication skills, both written and verbal; proven history of building collaboration across multi-disciplinary teams.
- Strong analytical capabilities and meticulous attention to detail, with the ability to effectively manage competing priorities.
- Quality certifications such as ASQ or ISO 9000 Auditor Training are highly desirable.
Why Join Us?
Be part of a dynamic, mission-driven CDMO dedicated to scientific excellence, innovation, and people-focused leadership. Our team members enjoy a comprehensive benefits package, including medical, dental, vision, and a company-matching 401(k) plan. We celebrate diversity and are committed to providing equal employment opportunities to all qualified individuals based on merit and without regard to age, disability, ethnicity, gender, marital status, race, religion, sexual orientation, or gender identity, in accordance with governing laws.
Ready to take the next step in your career and make an impact in a leading-edge pharmaceutical environment? Apply today to join a collaborative team that values integrity, quality, and growth
What happens next:
Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
