Quality Assurance Manager

Job Description

Job Description

The Quality Assurance Manager will lead all aspects of the quality function, ensuring operations consistently meet regulatory expectations, including compliance with 21 CFR Part 111. This position plays a critical role in shaping quality systems, maintaining documentation integrity, supporting audits, and partnering cross-functionally to uphold product quality and safety standards. The role also drives continuous improvement initiatives and fosters a strong culture of compliance throughout the organization.

Key Duties and Responsibilities

• Supervise and develop Quality team members through coaching, performance feedback, and structured training in GMP principles and internal procedures.
• Establish, implement, and monitor SOPs to ensure ongoing compliance with 21 CFR Part 111 and related regulatory standards.
• Plan and manage inspections and audits conducted by regulatory agencies and third parties, including preparation activities and resolution of any observations.
• Oversee company-wide training compliance by managing onboarding programs, GMP education, SOP instruction, and qualification tracking.
• Maintain oversight of document control processes, including the creation, revision, and accuracy of Master Manufacturing Records (MMRs) and Batch Production Records (BPRs).
• Lead investigations into quality events such as deviations, nonconformances, and Out-of-Specification (OOS) results, ensuring effective root cause analysis and CAPA implementation.
• Direct supplier quality management activities, including vendor approval, ongoing performance evaluation, and raw material risk assessments.
• Verify that product formulations, specifications, and labeling meet all applicable regulatory and customer requirements prior to release.
• Govern change control procedures to evaluate and document the impact of changes on product quality and compliance.
• Act as the primary liaison for customer-related quality matters, including agreements, documentation requests, and technical communications.
• Manage the review and response process for customer complaints, including trend monitoring and corrective action implementation.
• Maintain a state of readiness for inspections by ensuring alignment with dietary supplement cGMP requirements at all times.
• Collaborate with production and packaging teams to ensure processes consistently meet defined quality and safety standards.
• Execute internal audit programs to assess adherence to regulatory expectations and internal policies.
• Track, analyze, and interpret quality data to identify trends, mitigate risks, and support continuous improvement initiatives.

Required Qualifications

• Bachelor's degree in a scientific or technical discipline such as Food Science, Chemistry, Biology, or Quality Systems.
• At least 5 years of experience in quality assurance within dietary supplements, food manufacturing, or pharmaceutical environments.
• In-depth knowledge of 21 CFR Part 111, cGMP regulations, FDA requirements, and quality management systems.
• Hands-on experience with audit management, CAPA processes, supplier quality programs, and regulatory inspections.
• Experience working with electronic document control systems and quality management software

Compensation: $110,000 to $120,000 plus commission and full benefits

If this sounds like the position you have been waiting for, please apply using the online application or the link below - all inquiries are strictly confidential. Our focus is to assist you to make your best next career move, and we will not use your information for any other purpose.

Kalon Executive Search is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.