Director of Quality

DIRECTOR OF QUALITY Kellyu00ae 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 youu2019re 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 u2013 $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. Schedule: Day shift (on-site) 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: + Bacheloru2019s 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, youu2019ll proceed to the next steps if your skills and experience are a good match. Even if this position isnu2019t the right fit, youu2019ll remain part of our networku2014giving our team of expert Science & Clinical recruiters continued access to your profile and opening the door to future opportunities. p#1 As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. Why Kelly u00ae Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worldu2019s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsu2014itu2019s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About Kelly Work changes everything. And at Kelly, weu2019re obsessed with where it can take you. To us, itu2019s about more than simply accepting your next job opportunity. Itu2019s the fuel that powers every next step of your life. Itu2019s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your lifeu2014just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of Californiau2019s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellyu2019s Human Resource Knowledge Center. Kelly complies with the requirements of Californiau2019s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Created: 2026-04-27