Website Kelly
Kelly
Company : Kelly
Quality Assurance Manager
Kelly Science & Clinical is seeking a Quality Assurance Manager for a direct hire position at a manufacturing company in Loveland, CO. 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: $130k-160k, depending on experience
Overview: In this role, you will oversee and drive both Quality Assurance and Quality Control for a fast-growing, highly regulated manufacturing site, owning strategy, systems, and team development to ensure products consistently meet domestic and international standards. You'll report to the COO, shape the quality function with significant autonomy, build and mentor your team, and act as the trusted expert navigating regulatory compliance, industry growth, and expansion into global markets.
Schedule: Monday-Friday, standard working hours
Responsibilities:
- Lead and manage both Quality Assurance (QA) and Quality Control (QC), overseeing quality systems, documentation, product releases, and laboratory work for all manufacturing activities.
- Design, implement, and continuously improve the Quality Management System to align with FDA requirements and support international regulatory standards.
- Mentor and develop the existing quality team, assess staffing needs, and plan for team expansion as the business grows.
- Serve as the key compliance partner to the COO, collaborating daily with Operations, Regulatory, Research & Development, and Commercial teams to resolve product quality and risk issues.
- Provide guidance and strategic support for entering and maintaining compliance in international markets, including understanding novel foods regulations and other global certifications.
- Monitor quality metrics, drive a culture of continuous improvement and accountability, and respond rapidly to new challenges as the company scales.
- Coordinate and prepare for audit activities including internal, customer, and regulatory inspections, while ensuring proper execution of corrective actions, change controls, and complaint management.
- Guarantee reliable laboratory testing and data integrity in partnership with internal and third-party labs, integrate safety standards into quality practices, and promote a safety-first mindset throughout the department.
Qualifications:
- 10+ years of progressive experience in Quality within food, dietary supplement, or related regulated manufacturing environments.
- Strong experience with FDA and cGMP requirements relevant to food/supplement manufacturing.
- Proven ability to manage and comply with complex international regulatory requirements.
- Proven leadership of QA and QC teams, including hiring, developing, and coaching staff.
- Track record of designing and improving Quality Management Systems, including CAPA, change control, investigations, and audit programs.
- Experience supporting or leading regulatory and customer audits/inspections, and translating regulatory expectations into practical, scalable processes.
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.