Director of Regulatory Compliance

About the role

The Director of Regulatory Compliance provides strategic leadership and oversight for the regulatory, compliance, and scientific functions/initiatives across CROPP/Organic Valley. This role is essential to the FSQA leadership team and oversees all aspects of the implementation, management, and development of processes that ensure products, claims, research, and operations meet all applicable regulatory requirements while advancing the organization's technical foundations and streamlining the innovation pipeline.

Responsibilities

• Act as the primary liaison with regulatory agencies, industry groups, and internal stakeholders, guiding the company through an evolving regulatory landscape.
• Serve as the organization's subject matter expert in regulatory compliance concerning local, state, federal, and international requirements.
• Maintain and enhance Organic Valley's presence within critical trade organizations to advocate for cooperative interests and influence sound, sensible rulemaking.
• Support and represent the organization during regulatory inspections, audits, and inquiries.
• Monitor regulatory body priorities/initiatives and industry emerging issues.
• Provide written feedback and position papers on proposed government rules and trending regulatory events.
• Oversee compliance with food defense standards, including training, auditing, and continuous improvement.
• Act as subject matter expert and internal resource for PMO compliance.
• Support NCIMS policy development, comments, and industry alignment.
• Manage Organic System Plan standards that support enterprise-wide compliance.
• Ensure tools and companywide preparedness for organic inspection preparation, assessment, and post-inspection corrective actions.
• Manage Organic System Plan standards that support enterprise-wide compliance.
• Ensure CROPP/Organic Valley's leadership related to Organic standards and integrity.
• Provide expertise on labeling compliance across FDA, State, USDA, and NOP requirements.
• Oversee packaging rules, state-specific requirements, and retail label compliance.
• Oversee the Foreign Supplier Verification Program (FSVP), including hazard analyses, documentation review, supplier assessments, and reassessments every three years or upon changes.
• Support international supplier approval and onboarding, including compliance reviews and hazard analyses.
• Maintain and optimize processes for international shipments under the USDA Export Verification Program.
• Ensure compliance with organic equivalency and trade arrangement requirements.
• Develop and submit NOSB public comments; influence rulemaking and sunset list decisions to protect organic integrity.
• Engage with OTA, ACA, OTCO, NOP, NOSB, IDFA, and other key industry groups to foster alignment and advocate for cooperative interests.
• Provide leadership on complex industry issues and emerging regulatory challenges.
• Conduct quarterly internal stakeholder meetings on potential fraud and industry affairs.

Requirements

• Expert Knowledge of the PMO
• Strong Knowledge of 21 CFR Part 117
• Expert Knowledge of 21 CFR Part 1 (Subparts L-O)
• Expert Knowledge of 21 CFR Part 101
• Knowledge of FSMA 204
• Knowledge of 21 CFR 121
• Knowledge of 9 CFR 590
• Knowledge of 21 CFR 112
• Knowledge of Unique State Dairy Requirements
• Knowledge of Microsoft Office Programs
• Knowledge of HACCP/HARPC and GMP
• Knowledge of SAP
• Excellent verbal and written communication skills
• Strong research skills
• Dairy/plant experience preferred
• Self-directed and willing to work under minimum supervision
• 10+ Years of Quality Assurance/Food Safety experience with a focus on Regulatory Compliance
• Bachelor’s Degree, ideally STEM, or equivalent work experience required

Qualifications

• Expert Knowledge of the PMO
• Strong Knowledge of 21 CFR Part 117
• Expert Knowledge of 21 CFR Part 1 (Subparts L-O)
• Expert Knowledge of 21 CFR Part 101
• Knowledge of FSMA 204
• Knowledge of 21 CFR 121
• Knowledge of 9 CFR 590
• Knowledge of 21 CFR 112
• Knowledge of Unique State Dairy Requirements
• Knowledge of Microsoft Office Programs
• Knowledge of HACCP/HARPC and GMP
• Knowledge of SAP
• Excellent verbal and written communication skills
• Strong research skills
• Dairy/plant experience preferred
• Self-directed and willing to work under minimum supervision
• 10+ Years of Quality Assurance/Food Safety experience with a focus on Regulatory Compliance
• Bachelor’s Degree, ideally STEM, or equivalent work experience required

Skills

• Expert Knowledge of the PMO
• Strong Knowledge of 21 CFR Part 117
• Expert Knowledge of 21 CFR Part 1 (Subparts L-O)
• Expert Knowledge of 21 CFR Part 101
• Knowledge of FSMA 204
• Knowledge of 21 CFR 121
• Knowledge of 9 CFR 590
• Knowledge of 21 CFR 112
• Knowledge of Unique State Dairy Requirements
• Knowledge of Microsoft Office Programs
• Knowledge of HACCP/HARPC and GMP
• Knowledge of SAP
• Excellent verbal and written communication skills
• Strong research skills
• Dairy/plant experience preferred
• Self-directed and willing to work under minimum supervision
• 10+ Years of Quality Assurance/Food Safety experience with a focus on Regulatory Compliance
• Bachelor’s Degree, ideally STEM, or equivalent work experience required

Benefits

• Comprehensive Health Insurance
• Supplemental insurances: accidental insurance, critical illness insurance, and hospital indemnity insurance
• Time Off: 136 hours in the 1st year of employment prorated by start date. Plus 9 paid holidays, plus one floating holiday to use at will.
• 6 Weeks Paid Parental Leave
• Vision & Dental Insurance
• 401k: We match 100% up to the first 3% of an employee’s contribution, and then 50% for 3.1%-5.0% of employee contributions
• Tuition Reimbursement: Up to $1,500 per year to support continuing higher education
• Life Insurance: $50,000 policy funded by CROPP for each employee. Supplemental voluntary coverage available for employees, spouses, and children
• Short-Term & Long-Term Disability/AD&D Insurance: $50,000 of life insurance coverage of $50,000 of AD&D coverage funded by CROPP for each employee
• Employee Assistance Program: Free and Confidential for employees, spouses, and dependents
• Free onsite fitness centers available 24/7
• Biometric screenings (cholesterol, glucose, blood pressure) and health coaching
• Financial advisors and seminars
• Annual $360 Lifestyle Spending Account
• Flexible Scheduling
• On-site all-organic cafeterias