Quality Manager

Quality Manager - Dietary Supplements / Nutraceuticals

Position Overview


We are seeking a hands-on Quality Manager to lead and support quality assurance, compliance, and quality systems within a dietary supplement and nutraceutical manufacturing environment. This role combines strategic quality leadership with day-to-day execution of quality programs, supplier quality management, audits, investigations, testing support, and regulatory compliance activities.

The ideal candidate will possess strong knowledge of FDA regulations, cGMP requirements, quality management systems, and laboratory operations, along with the ability to work collaboratively across manufacturing, regulatory, R&D, and customer-facing teams.

Key Responsibilities


Maintain and administer the Quality Management System (QMS) in compliance with FDA 21 CFR Part 111 and applicable regulatory requirements.

Ensure adherence to cGMP standards, ISO requirements, SOPs, and internal quality policies.

Lead supplier qualification activities, supplier audits, and ongoing supplier quality assurance programs.

Conduct internal quality audits and support external audits as required.

Develop and deliver quality-related training programs for employees.

Review and approve raw material and finished product Certificates of Analysis (COAs).

Implement and manage customer quality agreements.

Represent Quality during customer meetings, site visits, regulatory inspections, and third-party audits.

Collaborate with R&D, Production, Regulatory Affairs, and Operations teams to ensure quality is integrated throughout product development and manufacturing processes.

Support product stability studies and shelf-life determination programs.

Review and approve analytical methods, specifications, test results, and laboratory documentation.

Participate in routine inspections, testing activities, and quality evaluations as needed.

Investigate deviations, non-conformances, out-of-specification (OOS) results, and customer complaints using CAPA methodologies.

Manage retain sample programs, including organoleptic evaluations of production lots.

Monitor, analyze, and trend quality metrics to identify opportunities for continuous improvement.

Qualifications


Strong knowledge of FDA regulations, including 21 CFR Part 111.

Thorough understanding of cGMP requirements, ISO standards, and Quality Management Systems.

Experience conducting audits, investigations, root cause analysis, and CAPA activities.

Strong documentation, organizational, and problem-solving skills.

Excellent communication and cross-functional collaboration abilities.

Comfortable working in a hands-on manufacturing environment.

Proficiency with Microsoft Office Suite.

Experience with SharePoint, document control systems, or similar platforms preferred.

ERP system experience is a plus.

Education & Experience


Bachelor's degree in Chemistry, Microbiology, Food Science, Quality Assurance, or a related scientific discipline.

3-7 years of quality management and laboratory operations experience within the dietary supplement, nutraceutical, food, or related regulated manufacturing industry.

What You'll Bring


Strong regulatory compliance expertise.

Proven ability to drive quality initiatives and continuous improvement.

Hands-on approach to quality management and operational support.

Ability to build strong relationships with suppliers, customers, and internal stakeholders.

Commitment to product quality, customer satisfaction, and regulatory excellence.