Manager, Quality

Helaina•New York, NY

95d•$115,000 - $135,000•Hybrid

About The Position

We are looking for a detail-oriented, scientifically-minded quality and compliance leader to own Helaina’s quality, and regulatory strategy. You will be responsible for everything from building and maintaining our Quality Management System to supporting commercialization efforts and label compliance. This role requires a unique blend of technical regulatory expertise, cross-functional collaboration, and the grit to navigate complex compliance landscapes in a fast-moving startup.

Requirements

5+ years of experience in Quality or Regulatory roles, with a proven track record in food, biotech, nutraceutical, or specialty ingredient environments.
Familiar with GLP, CGMP, and regulatory requirements including FSSC22000, FSVP, ISO, BRC, and SQF standards, including HACCP systems.
Experience building or managing supplier qualification programs and conducting third-party audits.
Comfortable reading regulatory guidance documents and translating requirements into operational SOPs and compliance programs.
A self-starter with the grit to handle everything from high-level compliance strategy to hands-on documentation and QC execution.

Nice To Haves

Experience supporting commercial teams with label reviews, claims substantiation, and regulatory submissions across domestic and international markets is a strong plus.

Responsibilities

Manage registration and certification processes as needed.
Manage the Supplier Qualification Program by auditing and approving co-manufacturers and distribution centers.
Correspond with co-manufacturers regarding raw ingredients, formulation, certifications, test methods, and manufacturing steps throughout the product development process.
Maintain the Quality Management System for Helaina.
Support the regulatory team on items related to selling in additional jurisdictions.
Establish and manage testing programs for products, materials, and packaging.
Review audit results and oversee investigations into process deviations to address issues identified from testing activities.
Oversee QC tasks, ensuring proper documentation of records and review of reports submitted to regulatory authorities.
Establish product and process quality metric reports; report data trends, results, and potential implications of QC data to stakeholders.
Assist the marketing and sales team with scientific research, formulation, and claims substantiation for dietary supplement products.
Perform label compliance reviews for domestic and international retailers and distributors.
Develop quality documentation for each product.
Support the sales team on sales-related efforts on the quality, regulatory, and safety front.