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.