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Monterey Bay Herb Company

Director of Quality and Regulatory Compliance

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What they do

A Compliance Manager tracks employer compliance with laws and regulations, particularly for organizations in business and health care. Creates company policies, reviews departmental functions and protocol, follows developments in law and regulations affecting the industry

$174,434 / year median in California

-2% projected decline

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Job Description

1.0 Job Summary (Objective) Leads and manages the Quality Management Systems, Food Safety Programs, Supplier Quality Programs, and Regulatory Compliance functions for Monterey Bay Herb Company and NP Nutra (NPHERBCO). Responsible for harmonizing quality systems across both organizations while ensuring compliance with applicable FDA regulations, certification schemes, customer requirements, and industry best practices. While both organizations operate under 21 CFR Part 117, this role ensures NP Nutra maintains quality, documentation, traceability, supplier qualification, and GMP-based programs that support customers operating within the dietary supplement industry. Provides strategic leadership for quality personnel at multiple facilities, including regular onsite oversight of the Carson, California location. 2.0 Core Responsibilities Food Safety & Regulatory Compliance
  • Own and maintain enterprise Quality Management Systems and Food Safety Programs for both companies.
  • Ensure compliance with
FSMA, 21 CFR
Part 117, SQF, Organic, Kosher, GMP and other customer requirements and certifications.
  • Serve as primary contact during regulatory inspections, customer audits and certification assessments.
  • Maintain audit readiness across all facilities.
  • Monitor and actively provides guidance on any claims substantiation made in all marketing collateral, websites etc. Quality System Ownership & Harmonization
  • Own structure, effectiveness and continuous improvement of all QMS programs.
  • Standardize policies, procedures and records where appropriate across both businesses.
  • Oversee document control, training, CAPA, change management and traceability systems.
  • Process Customer complaints, Material Returns and companywide quality document requests, with associated metrics and time fences established for visibility and managing expectations.
  • Partner with Operations and IT to improve efficiency and compliance. Supplier Quality & Product Compliance
  • Lead supplier and material approval and qualification programs.
  • Oversee specifications, quality agreements, risk assessments and supplier performance.
  • Implement controls supporting dietary supplement customer expectations regarding ingredient quality and documentation. Quality Operations
  • Oversee incoming inspection, testing, release, quarantine and material disposition processes.
  • Ensure lot traceability and data integrity.
  • Drive root-cause investigations and corrective actions. Leadership & Travel Requirements
  • Lead and develop Quality and Regulatory teams across Monterey Bay Herb Company and NP Nutra.
  • Provide direct oversight of MBHC and NP Nutra quality personnel.
  • Travel monthly to Carson, California to conduct audits, training, coaching, management reviews and quality system assessments.
  • Support suppliers, customers and strategic initiatives through additional travel as needed.
3.0 Certifications & External Audits Manage multi-site SQF, Organic, Kosher and other applicable certification programs. Maintain readiness for customer, regulatory and third-party audits. 4.0 Education and Certification Requirements Bachelor's degree in Food Science, Microbiology, Chemistry, Biology, Quality Assurance, Regulatory Affairs, or a related technical field required; advanced degree preferred. Equivalent combination of education and senior-level quality/regulatory leadership experience in food, botanical, ingredient, dietary supplement, or regulated manufacturing environments may be considered. PCQI certification
  • HACCP certification
  • SQF Practitioner training, and internal or lead auditor training strongly preferred.
Additional certifications such as
ASQ CQA, ASQ
CMQ/OE, GMP, Organic, Kosher, or Regulatory Affairs credentials are preferred. English/Spanish speaking prefered
Pay:
$120,000.00
  • $150,000.
00 per year
Benefits:
401(k) Dental insurance Health insurance Paid time off Vision insurance
Location:
Watsonville, CA 95076 (Preferred) Ability to
Commute:
Watsonville, CA 95076 (Preferred)
Work Location:
In person

Benefits

  • Paid Time Off (PTO)
  • 401(k) Plans
  • Health Insurance
  • Dental Insurance