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Quality Assurance Manager
- New York, New York, United States
- New York, New York, United States
Über
Quality Assurance (QA) Manager
to lead and oversee quality systems for our growing dietary supplement brand. This role is responsible for ensuring product quality, safety, and brand integrity across all contract manufacturers, suppliers, and distribution partners.
As a brand-driven organization, quality is central to our reputation. The QA Manager will serve as the quality authority, ensuring our products meet FDA dietary supplement regulations (21 CFR Part 111 and 117), labeling requirements, and third-party certification standards while protecting consumer trust.
Key Responsibilities Quality Oversight of Contract Manufacturers
Communicate with manufacturers (CMOs) to ensure compliance with 21 CFR Part 111 and 117 as well as cGMP requirements.
Review and approve Master Manufacturing Records (MMRs), Batch Production Records (BPRs), and Certificates of Analysis (COAs).
Complete and own finished product release and disposition decisions that do not require escalation.
Regulatory & Compliance
Maintain inspection readiness.
Oversee adverse event reporting and complaint investigations.
Documentation & Quality Systems
Utilize the company’s Quality Management System (QMS).
Manage SOPs, document control, change control, deviations, and CAPAs.
Participate in review and approval of finished product specifications.
Track quality metrics and prepare multi-level reporting.
Customer & Brand Protection
Oversee customer complaint investigations and trending analysis.
Participate in recall readiness planning and mock recalls in coordination with operations.
Protect brand integrity by proactively identifying quality risks.
Cross-Functional Collaboration
Partner with Product Development, Regulatory, Marketing, Supply Chain, and Operations teams to ensure quality is embedded from concept to commercialization.
Participate in cGMP and quality training to internal teams.
Qualifications Education:
Bachelor’s degree in Food Science, Chemistry, Microbiology, Pharmaceutical Sciences, Regulatory Affairs, or related field.
Experience:
6–10+ years of quality assurance experience in dietary supplements.
Experience working with contract manufacturers (CMOs).
Strong knowledge of FDA dietary supplement regulations (21 CFR Part 111, 117 & Part 101).
Experience with third-party certifications (e.g., NSF, USP, Non-GMO, Organic) preferred.
Strong understanding of brand protection and regulatory risk management.
Excellent documentation and technical writing skills.
Strategic thinker with the ability to balance compliance and business growth.
Strong communication and leadership abilities.
Key Performance Indicators (KPIs)
Timely batch release and deviation closure
Reduction in complaint trends
Monthly Quality and CMO data share
Ad hoc KPIs are requested
This position may be performed remotely within the United States where permitted by applicable law. At this time, we are not considering applicants residing in the following states: California, Colorado, New York, Washington, Oregon, New Jersey, Minnesota, Massachusetts, Maine, Wisconsin, Pennsylvania, or Ohio.
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Sprachkenntnisse
- English
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