Executive Summary
The Quality Manager is responsible for ensuring the quality of all products in compliance with regulatory standards, internal quality policies, and industry’s best practices. This role has a strong component of supplier quality oversite, management and relationship building. This role combines tactical quality management with hands-on quality control oversight, ensuring product safety, efficacy, and consistency within the dietary supplement space.
Key Responsibilities
· Maintain and execute a comprehensive quality management system (QMS) in accordance with FDA 21 CFR Part 111 and other applicable regulations.
- Oversee and have direct involvement in supplier qualification, audits, and ongoing supplier quality assurance.
· Conduct internal audits in accordance with appropriate SOP’s.
· Train staff on quality standards, policies, and procedures.
· Review and approve all final product Certificates of Analysis for delivery to our customers.
· Review raw material COA’s prior to production activities.
· Implement customer quality agreements.
· Participation in customer meetings and site visits.
· Quality representative during FDA inspections and customer audits.
· Collaborate with R&D, production, and regulatory teams to ensure quality is built into all stages of product development and manufacturing.
· Direct involvement in product stability programs and shelf-life determination.
· Approve and review test methods, analytical data, and specifications for raw materials, in-process materials, and finished products.
· Direct involvement as needed in product quality through routine testing and inspections.
· Investigate deviations, out-of-specification results, and customer complaints (using our CAPA system).
· Direct involvement in the retain sample program including organoleptic assessment of initial versus subsequent production lots.
· Drive continuous improvement initiatives through tracking and trending quality metrics (complaints, deviations and audit findings).
Performance Bonus - 10 to 15% per year
QUALIFICATIONS
· Strong knowledge of FDA regulations (21 CFR, Part 111), cGMP, ISO standards, and QMS principles.
· Strong leadership and interpersonal skills with cross-functional collaboration experience.
· Excellent documentation, auditing, and problem-solving skills.
EDUCATION and EXPERIENCE
- Bachelor’s degree in chemistry, Microbiology, Food Science, or related field.
- Minimum of 3–7 years’ experience in dietary supplement or nutraceutical quality management and laboratory operations.
COMPUTER SKILLS
• To perform this job successfully, an individual must be proficient with MS Office Suite. Knowledge of SharePoint and /or other shared folder software. ERP experience an additional plus.
SKILLS AND ABILITIES
• Product and Technical Knowledge
• General regulatory knowledge
• Managing Project Communication
• Quality Focus
• Data Analysis and Interpretation
PERSONAL CHARACTERISTICS
As an entrepreneurial company, WIN Nutrition/Oceana Health values:
• Interpersonal Skills
• Customer Focus
• Innovation
• Integrity
• Operational Discipline
• Teamwork
• Humility