About the Role
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.
What you’ll do:
Quality & Regulatory
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.
Support on Commercialization Efforts
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.
About you:
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.
You have experience building or managing supplier qualification programs and conducting third-party audits.
You are comfortable reading regulatory guidance documents and translating requirements into operational SOPs and compliance programs.
Experience supporting commercial teams with label reviews, claims substantiation, and regulatory submissions across domestic and international markets is a strong plus.
A self-starter with the grit to handle everything from high-level compliance strategy to hands-on documentation and QC execution.
Must be willing to travel occasionally to engage with co-manufacturers, auditors, and industry partners.
Location: Hybrid NYC or Remote
Compensation is market-competitive with a yearly cash base of $115k - $135k plus equity.
Skills Required
- 5+ years of experience in Quality or Regulatory roles in food, biotech, nutraceutical, or specialty ingredient environments.
- Familiarity with GLP, CGMP, FSSC22000, FSVP, ISO, BRC, SQF, and HACCP systems.
- Experience building or managing supplier qualification programs and conducting third-party audits.
- Experience maintaining a Quality Management System (QMS), establishing testing programs, and overseeing QC documentation and reporting.
- Ability to read regulatory guidance and translate requirements into operational SOPs and compliance programs.
- Willingness to travel occasionally to engage with co-manufacturers, auditors, and industry partners.
- Experience supporting commercial teams with label reviews, claims substantiation, and regulatory submissions across domestic and international markets.
- Self-starter capable of both high-level compliance strategy and hands-on documentation and QC execution.
Helaina Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Helaina and has not been reviewed or approved by Helaina.
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Healthcare Strength — Health coverage includes full medical, dental, and vision alongside short- and long-term disability insurance. Feedback suggests this breadth is clearly communicated across current job materials.
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Parental & Family Support — Support includes paid parental leave for both parents, childcare reimbursement, and a flexible return-to-work approach. These elements indicate substantive family-oriented benefits.
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Leave & Time Off Breadth — Time off includes an “unlimited” vacation policy and an all-company winter holiday closure. This breadth is presented consistently in public postings.
Helaina Insights
What We Do
Helaina is a biotech company pushing the boundaries of what food can do for health.
