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Director of Quality and Regulatory Compliance

Job in Hauppauge, Suffolk County, New York, 11788, USA
Listing for: Randstad USA
Full Time position
Listed on 2026-08-22
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers, QA Specialist - Analyst/Manager
Salary/Wage Range or Industry Benchmark: 150000 - 160000 USD Yearly USD 150000.00 160000.00 YEAR
Job Description & How to Apply Below

A leading dietary supplement manufacturer is seeking a hands‑on leader to direct the site Quality Unit. This role owns the cGMP quality management system, leads third‑party and regulatory audits (FDA, NSF), and holds final release/quarantine authority over all materials and finished products.

If you thrive in an active manufacturing environment, bring deep regulatory expertise, and want direct executive backing to enforce high quality standards, we want to hear from you.

salary: $150,000 - $160,000 per year

shift:
First

work hours: 8 AM - 5 PM

education:
Bachelors

Responsibilities
  • QMS & Compliance: Maintain and continuously improve the site Quality Management System in full alignment with 21 CFR Part 111, Part 117, and NSF/ANSI 455-2 standards.
  • Audit Leadership: Serve as primary host for FDA, NSF, customer, and third-party inspections; manage audit prep, responses, and CAPA closures.
  • Batch Release & Authority: Exercise final, independent authority over product disposition (quarantine, hold, release, reject) for raw materials, in-process goods, and finished products.
  • Investigations & Lab Oversight: Lead root‑cause analyses, CAPAs, OOS investigations, and deviations. Direct internal/external lab testing, analytical methods, stability programs, and COAs.
  • Labeling & Vendor

    Qualification:

    Oversee vendor qualification programs and collaborate with legal/R&D to review product labels, Supplement Facts, and claims.
  • Team Leadership: Direct and mentor the QA/QC team, implement site‑wide cGMP training, and maintain continuous inspection readiness.
  • Education: Bachelor's degree in Chemistry, Biochemistry, Food Science, Microbiology, or a related scientific field.
  • Experience:
    • 8+ years of progressive quality experience in dietary supplement, nutraceutical, or pharma manufacturing.
    • 3+ years in a supervisory or managerial quality/regulatory role.
  • Technical Expertise: Expert knowledge of 21 CFR Part 111 and hands‑on experience leading NSF/ANSI 455-2 or FDA audits.
Skills
  • Quality Assurance
  • Quality Control
  • Regulatory Compliance - Other
  • Product Inspection
  • Testing
  • Regulatory reporting
  • Managing
  • Operations
Qualifications
  • Years of experience: 8 years
  • Experience level:
    Director

Equal Opportunity

Employer:

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

Experience
  • Director
  • 8 years
Education
  • Bachelors
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