Quality Manager

Job Description

Job Description

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