Summary/Overview
The Director of Quality & Regulatory Affairs is responsible for ensuring that all products
manufactured at the facility meet regulatory, quality, and safety standards. This role leads the development, implementation, and oversight of the Quality Management System (QMS), ensuring compliance with cGMP requirements (21 CFR Part 111), NSF/ANSI 455-2 standards, and applicable FDA, state, and international regulations.
The Director partners with Production, R&D, Supply Chain, and senior leadership to align quality initiatives with company goals, drive continuous improvement, and safeguard the integrity of products throughout their lifecycle.
Position Responsibilities
1. Quality System Leadership
a. Lead the design, implementation, and continuous improvement of the Quality Management System to meet 21 CFR Part 111 and NSF/ANSI 455-2 requirements.
b. Ensure readiness for FDA inspections, third-party audits, and customer audits by maintaining a culture of compliance.
c. Take appropriate actions to ensure the integrity of the Quality System, including risk assessments and CAPA (Corrective and Preventive Actions).
d. Oversee the maintenance of all FDA & state licenses, registrations, and regulatory filings.
2. Regulatory Affairs
a. Ensure compliance with applicable FDA regulations, dietary supplement labeling laws, and international regulatory requirements.
b. Collaborate with R&D and marketing to review labels, claims, and formulations for regulatory compliance.
c. Serve as the point of contact for government and regulatory agencies, managing all correspondence, reporting, and audit responses.
d. Maintain current knowledge of changes to relevant laws, regulations, and industry guidance.
e. Partner with customers to support their stability programs, shelf-life verification, and other regulatory needs.
3. Auditing & Verification
a. Develop and oversee internal audit programs to verify compliance with prerequisite programs and SOPs.
b. Review and approve Batch Production Records (BPRs) for accuracy and compliance prior to release .
c. Audit laboratory test results and maintain Certificates of Analysis (COAs) for all products.
d. Oversee third-party laboratory relationships, ensuring timely and accurate testing for raw materials and finished goods.
4. Documentation & SOPs
a. Lead the development, approval, and maintenance of Standard Operating Procedures (SOPs) for production, quality, and regulatory functions.
b. Manage change control processes for formulas, Master Manufacturing Records (MMRs), and controlled documents .
c. Ensure proper documentation of deviations, non-conformances, and investigations.
d. Create and maintain in-process and finished product specifications in collaboration with R&D.
5. Training & Development
a. Establish training programs to ensure all employees are competent to perform functions affecting product safety and quality .
b. Conduct cGMP, HACCP, and regulatory compliance training for Quality, Production, and cross-functional teams.
c. Coach and develop direct reports, building strong leadership within QA/QC and regulatory teams.
6. Cross-Functional Collaboration
a. Partner with R&D to support new product development, including formulation reviews, MMR creation, and product launches.
b. Work closely with Production and Supply Chain to ensure timely material release, production scheduling, and compliance with customer requirements .
c. Act as a liaison between Quality and business stakeholders, ensuring alignment on deadlines and deliverables.
7. Continuous Improvement
a. Monitor key performance indicators (KPIs) related to quality and regulatory performance.
b. Implement continuous improvement initiatives to reduce defects, improve compliance, and streamline processes.
c. Leverage technology such as DataNinja or ERP/QMS platforms for digital batch records, label control, and quality reporting.
Minimum Qualifications
Education: Bachelor’s degree in Chemistry, Microbiology, Life Sciences, Regulatory Affairs, or a related field (Master’s preferred)
Experience:
1. Minimum 7-10 years of experience in dietary supplement, pharmaceutical, food, or cosmetic manufacturing, with at least 5 years in Quality or Regulatory leadership roles .
2. Demonstrated success managing FDA and third-party audits, regulatory submissions, and cross-functional teams.
3. Hands-on experience with cGMP-compliant manufacturing, product labeling regulations, and supplier qualification
Knowledge, Skills and Abilities:
1. Strong understanding of 21 CFR Parts 111, 117, 210, and 211, as well as HACCP and NSF/ANSI 455-2.
2. Proficient in Microsoft Office Suite and familiar with ERP/QMS platforms such as DataNinja.
3. Excellent leadership, interpersonal, and problem-solving skills with the ability to coach teams and drive compliance.
4. Strong written and verbal communication skills for regulatory submissions and cross-functional collaboration.
Certification or License:
1. ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).
2. Preventive Controls Qualified Individual (PCQI).
3. Better Process Control School (BPCS) certification.
Pay: $150,000.00 - $180,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
