Place of Performance: Onsite, San Diego, CA
Salary Range: $115,000 - $135,000
The Quality & Regulatory Compliance Manager is responsible for ensuring regulatory compliance, food safety, certification accuracy, and finished product integrity across all manufactured products. Reporting into FSQA, this role serves as a cross‑functional leader working closely with R&D, Operations, Supply Chain, Sales, and external partners to support product commercialization, regulatory accuracy, third‑party testing, certifications, and audit readiness. This position acts as a key external-facing technical contact for certifiers, laboratories, auditors, and customers.
Essential Duties and Responsibilities
Regulatory & Compliance
- Provide regulatory guidance, documentation, and approvals for new and existing products in compliance with FDA and applicable state regulations.
- Review and approve ingredient statements, nutrition and supplement facts, allergen disclosures, and claims to ensure accuracy and compliance.
- Create, review, and approve product master formulas, manufacturing procedures, product standards, quality standards, and regulatory documentation.
- Work directly with ingredient and packaging suppliers to obtain, review, and maintain required regulatory, quality, and certification documentation to support existing products and new product development.
- Ensure supplier documentation is current, accurate, and audit-ready for regulatory, certification, and customer requirements.
- Maintain regulatory databases, archives, and document management systems.
- Provide guidance and direction with cGMP requirements
Finished Product & Labeling
- Confirm that nutrition and ingredient labeling conforms to all Intelligent Blends standards and regulatory requirements.
- Review artwork and labeling for regulatory, nutritional, and ingredient accuracy prior to approval.
- Create nutritional facts panels and supplemental facts panels for new products
- Maintain finished product matrix with product, testing and certification requirements
Certifications & Audits
- Own and maintain all certification systems (Organic, Kosher, non-GMO, Gluten Free and Fair Trade) including documentation, supplier verification, and ongoing compliance.
- Serve as a key supporting participant during third‑party audits including SQF, Organic, Kosher, customer audits, and regulatory inspections; assist audit leads.
- Support internal audits and corrective actions to ensure audit readiness at all times.
- Support the designated SQF Practitioner in maintaining ongoing compliance with SQF Code requirements, including documentation, audit preparation, and corrective action support.
Food Safety & Testing
- Support, review, interpret, and communicate testing results internally and externally, including customer-facing communications.
- Support food safety programs including HACCP, preventive controls, and continuous improvement initiatives.
- Support Operations and serve as a backup to FSQA Technicians
Product Development Support
- Provide expert regulatory guidance on new projects during the product vetting process
- Proactively manage all elements of regulatory compliance for each stage of product development (to include advising on ingredient selection, supplier documentation, and product certifications)
- Manage communications with customers regarding regulatory compliance concerns with their products
Cross‑Functional Leadership
- Collaborate across departments to ensure timely submission of product-related reports, documentation, and certifications.
- Support continuous improvement initiatives related to quality systems, compliance, and documentation accuracy.
Specific Skills & Abilities
- Strong knowledge of FDA food and supplement regulations and quality systems and experience interpreting FDA guidelines across a variety of product formats
- Experience managing Organic, Kosher, Non‑GMO, and customer certification programs
- Experience reviewing and approving labels, artwork, and nutritional information
- Strong organizational, documentation, and attention-to-detail skills
- Cross‑functional leadership and effective communication skills
- Team‑oriented, proactive, and solutions-focused attitude
- Strong interpersonal skills and self-motivated
- Able to manage customer communications and advise as a regulatory compliance subject matter expert
Qualifications
- Minimum 3–5 years of experience in a supplement manufacturing environment. Food manufacturing experience a plus
- Experience supporting commercialization of food and beverage products
- Demonstrated experience in nutritional label creation and formulation adjustments to support compliant claims
- Prior experience assisting or leading third‑party audits (SQF, Organic, customer audits)
- Experience with supplement products preferred
- Familiarity with Prop 65 compliance
Education & Certification
- Bachelor’s degree in Food Science, Nutrition, Food Safety, or a related technical field, or equivalent experience
- SQF Practitioner designation required (or ability to obtain within a defined timeframe)
- HACCP certification required (or ability to obtain within a defined timeframe)