Director of Quality

JOB SUMMARY

The Director of Quality Control is a critical leadership role responsible for overseeing the company’s entire Quality Control (QC) and Quality Assurance (QA) operations. This individual ensures that all manufacturing processes and finished products meet the highest standards of safety and compliance in an FDA‑regulated environment. By providing strategic direction and technical expertise, the Director manages all quality systems, regulatory relationships, and team performance to support the company’s commitment to excellence.

• Team Development: Direct and mentor quality personnel team to ensure high performance and professional growth.
• Strategic Oversight: Lead the execution of the Quality Program and conduct annual Quality System performance reviews to drive continuous improvement.
• Operational
  
  Collaboration:
  
  Participate in the Management Team, interfacing with Operations, Finance, Scientific, Regulatory, CEO, and Ownership.
• Program Administration: Oversee the review and maintenance of Pest Control, Preventive Maintenance, Training, and Sanitation Programs.

• Regulatory Compliance: Represent the company during FDA and third‑party inspections, managing all post‑inspection CAPAs and required process changes.
• Quality Operations: Supervise the testing of ingredients, components, and finished products, including the disposition of out‑of‑specification (OOS) results.
• Product Release: Oversee the release of finished products and approve all Certificates of Analysis (COAs).
• Documentation Control: Manage a robust Document Change Control program and the approval of all new or revised SOPs.
• Audit & Safety: Lead internal cGMP and HACCP audits while maintaining the Food Defense Plan.
• Safety Monitoring: Direct investigations for Adverse Events and report findings to the FDA as required, as well as manage product complaints & inquiries.
• Recall Readiness: Conduct annual mock recalls and manage active product recalls if necessary.

• Environmental Monitoring: Conduct assessments including water testing and other essential environmental testing.
• Other duties as directed.

• Education: BS degree required;
  Masters or PhD in a technical degree in chemistry is strongly preferred.
• Technical
  
  Experience:
  
  At least 5 years of experience in a QC management role within an FDA‑regulated cGMP manufacturing environment specific to dietary supplements.
• Industry Background: Prior experience working with laboratories and a thorough understanding of analytical and microbial testing. Prior experience working in a dietary supplement manufacturing company required.
• Core Competencies: Strong attention to detail, advanced math skills, and proficiency in reading and writing English.
• Communication: Proven ability to communicate effectively to direct reports, executives, and other departments.
• Leadership Ability: Proven track record in training, managing, and directing employees and management‑level staff.

Full‑time

$ – $ per year

• 401(k)
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

• Do you have a degree in Chemistry?
• If not located in Northern Colorado, are you willing to relocate to Fort Collins, Loveland, or surrounding area of Colorado?

• Bachelor's (Required)

If you have any questions regarding the position, please contact us!