Head of Quality / Director of Quality

We are hiring a Head of Quality to own our 21 CFR 111 program end to end. This role reports directly to the CEO, holds final signature authority on batch release, complaint review, CAPA closure, supplier qualification, and product label approval, and is the primary quality signatory with FDA.

You will lead the response to our recent Form 483 and shape the quality architecture of our embedded QMS-in-ERP build (already underway). In addition to overseeing our in-house manufacturing you will own the quality agreement, on-site audit program, and governance of our Eurofins-certified contract manufacturer(s). Experience operating as the quality signatory at a virtual or brand-owner supplement company is highly valued.

Responsibilities

• Own all quality decisions and signatures under 21 CFR Part 111 and Part 11 electronic records requirements.
• Lead the March 2026 Form 483 response and all follow-up correspondence with FDA.
• Hold sole release authority for every finished lot distributed under the Neurogan label.
• Approve all master manufacturing records, specifications, SOPs, batch releases, and supplier qualifications.
• Author, negotiate, and enforce quality agreements with contract manufacturers; lead annual and for-cause on-site CM audits.
• Operate the Serious Adverse Event Reporting program per 21 USC 379aa-1 (15 business-day MedWatch filings, 6-year recordkeeping).
• Approve all labels, Supplement Facts panels, structure-function claims, and maintain the claims substantiation file.
• Serve as the qualified person for product complaint review (21 CFR 111.560).
• Partner with engineering to validate the embedded QMS build (URS sign-off, PQ execution, validation summary report).
• Lead inspection readiness for PAC 21008D Own-Label Distributor inspections; run annual mock recall and mock FDA inspection.
• Build and lead the quality team, starting with Carrie Treat (QC Analyst) and growing to include a QA Manager in 2028 as manufacturing fully outsources.
• Own internal audits, management review, CAPA effectiveness, trend analysis, and regulatory reporting.

Required qualifications

• 7 years in quality assurance at an FDA-registered dietary supplement, nutraceutical, or food-grade manufacturing / brand-owner facility.
• 3 years as QA Manager, Director of Quality, or equivalent signing authority.
• Direct experience responding to a 483 and participating in FDA inspections as the quality signatory.
• Hands-on experience authoring and enforcing contract-manufacturer quality agreements and leading on-site CM / supplier audits. Non-negotiable.
• Demonstrated experience authoring and approving Master Manufacturing Records, specifications, and batch records under 21 CFR 111.
• Strong working knowledge of 21 CFR Part 11 electronic records and signatures.
• Working knowledge of the Serious Adverse Event Reporting requirements under 21 USC 379aa-1 and DSHEA labeling.
• Bachelor's degree in a life science, chemistry, or related field. Advanced degree preferred.

Preferred qualifications

• CQA, CQM, RAB, or equivalent professional quality certification.
• Prior role as Head of Quality at a virtual or brand-owner supplement company (no in-house manufacturing).
• Experience hosting a PAC 21008D Own-Label Distributor FDA inspection.
• Experience transitioning quality oversight from in-house to contract manufacturing.
• Experience with custom-built ERP and QMS systems (not only off-the-shelf MasterControl or Veeva).
• Familiarity with supplement categories: botanicals, specialty ingredients (NMN, Urolithin A, creatine), pet supplements.

Pay: $125,000.00 - $160,000.00 per year

Benefits:

• Health insurance
• Relocation assistance

Application Question(s):

• How many times have you personally led a response to an FDA Form 483 and closed observations to FDA satisfaction?
• Which QMS software solutions do you have experience with?

Experience:

• Diet suppl. or nutra quality under 21 CFR Part 111 cGMP: 7 years (Required)

License/Certification:

• Do you have a PCQI or equivalent credential? (Required)

Work Location: In person

Salary : $125,000 - $160,000