**Director of Quality and Regulatory Affairs** Kelly® Science & Clinical is seeking a **Director of Quality and Regulatory Affairs** for a **direct-hire** position at a cutting-edge client in **Anaheim, CA.** 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. **Salary: $140,000-160,000** **Schedule: Day Shift. Onsite** **Overview** The Client is an industry-leading company that’s driving innovation in the nutraceutical sector. In this role, you will be responsible for developing, coordinating, and implementing quality and regulatory strategies and programs required for the development, regulatory approval, successful manufacture, commercialization, and post-market surveillance of its products. You will also serve as the Management Representative and Person Responsible for Regulatory Compliance under 21 CFR Part 111 and 117, while providing leadership and development to assigned teams and staff. **Responsibilities:** + Establish, implement, and manage the overall regulatory, quality assurance, quality control, and complaint handling functions to ensure the quality, safety, and reliability of all Client products. + Monitor the complete manufacturing and QA/QC process to ensure conformance and compliance and manage the Quality System in accordance with applicable local and federal regulatory requirements. + Continuously identify opportunities to improve the Quality System, product quality, simplify processes, and reduce the costs of quality. + Manage quality and regulatory staff and departmental resource needs. + Create and lead a high-performing, innovative management team that attracts, recruits, develops, and retains exceptional staff. **Qualifications:** + Bachelor’s degree in life sciences or related field required, advanced degree or certification in Quality or Regulatory preferred. + 10+ years of experience in the nutraceutical industry, including management experience. + Extensive experience in quality, regulatory, and dietary supplement industry, with strategic knowledge of USA and global regulations. + Proven experience interfacing with regulatory bodies such as FDA, Notified Bodies, and Competent Authorities. + Excellent knowledge of Quality Systems Regulations, cGMP, and 21 CFR Part 11, 111, and 117. + Strong statistical knowledge, teamwork orientation, workplace safety, and complaint handling systems. + Outstanding verbal and written communication skills, critical thinking, and organizational abilities. + Demonstrated success in building and leading high-performing, complex teams. **Competencies:** + People Manager competencies: Building talent, driving for results, Customer focus, Driving for innovation, Emotional intelligence. + Strategic thinking + Leadership, coaching, and mentoring + Financial management + Analysis and problem solving **Work Environment:** + The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. + Occasionally exposed to moving mechanical parts, fumes, airborne particles, and risk of electrical shock. + Noise level is usually moderate. + Required to use personal protective equipment while in the plant. + Specific vision abilities required include close vision, peripheral vision, and the ability to adjust focus. **What happens next:** Once you apply, you’ll proceed to 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. 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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. Why Kelly ® 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 world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s 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, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s 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 life—just 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 California’s 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 Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.