Job Description

Job Title: Quality Assurance Manager

Department: Quality

Reports To: Director of Quality Assurance

Employment Type: Full-Time

Job Summary:

The Quality Manager is responsible for leading and developing the Quality team while ensuring

full compliance with 21 CFR Part 111 and all applicable regulatory, customer, and internal

quality standards. This role oversees quality systems, documentation control, investigations,

supplier qualification, audit management, and customer quality support to ensure product safety,

compliance, and continuous improvement.

Key Responsibilities:

Manage and develop the Quality team through daily oversight, performance management,

coaching, and ongoing GMP and SOP training.

Ensure compliance with 21 CFR Part 111 through implementation, monitoring, and

execution of Standard Operating Procedures (SOPs) across the facility.

Lead regulatory and third-party audits, including audit preparation, hosting, coordination, and

timely response to audit findings.

Manage employee training compliance, including onboarding, GMP training, SOP training,

qualification programs, and maintenance of training records.

Own and maintain Master Manufacturing Records (MMRs), Batch Production Records

(BPRs), and controlled documentation systems to ensure accuracy and regulatory

compliance.

Own and manage deviation, nonconformance, Out-of-Specification (OOS), and CAPA

investigations through root cause analysis and timely closure.

Manage supplier qualification programs, including supplier approval, raw material risk

assessments, performance monitoring, and ongoing supplier evaluations.

Ensure product labeling, specifications, and formulations meet regulatory requirements and

customer specifications prior to release.

Execute and oversee change control activities impacting product quality, safety, compliance,

or documentation.

Manage customer quality agreements, technical questionnaires, and routine quality inquiries

to ensure alignment with regulatory and contractual obligations.

Investigate and draft responses to customer complaints, conduct trend analysis, and

implement corrective or preventive actions as needed.

Ensure audit readiness at all times and maintain programs aligned with applicable Dietary

Supplement cGMP standards.

Support manufacturing and packaging operations to ensure adherence to quality and product

safety standards.

Lead internal audit programs to verify compliance with regulatory requirements, cGMPs, and

internal procedures.

Collect, analyze, and trend quality data to identify opportunities for continuous improvement

and risk mitigation.

Perform other duties as assigned by management.

Qualifications:

Bachelor's degree in Food Science, Quality Management, Biology, Chemistry, or

a related scientific field.

5+ years of experience in quality assurance within dietary supplement, food, or

pharmaceutical manufacturing.

Strong working knowledge of 21 CFR Part 111, cGMP requirements, FDA

regulations, and quality systems management.

Experience managing audits, CAPA systems, supplier qualification programs,

and regulatory inspections.

Proven leadership experience with the ability to train, mentor, and develop

quality personnel.

Strong analytical, organizational, and problem-solving skills.

Excellent written and verbal communication skills.

Proficiency in document control systems and quality management software.

Additional Skills:

Strong leadership and decision-making abilities.

High problem-solving skills in fast-paced manufacturing environments.

Ability to manage multiple priorities and meet deadlines.

Analytical mindset with the ability to interpret regulations and apply them

practically.

Computing skills (Word, Excel, PowerPoint) to generate reports and maintain

records.

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