Risk Manager III, Whole Body, Dietary Supplements, OTC Drugs, and Bodycare

Whole Body Safety Manager is a role within the Food Safety & Quality organization, focusing primarily on Worldwide Grocery Stores (WWGS) Private Brands, including Amazon Grocery and Whole Foods Market 365. This position is responsible for ensuring the safety, compliance, and continuous improvement of supplier sites producing private label Dietary Supplements, Over the Counter medications, and bodycare products. The manager will lead facility approvals, conduct rigorous due diligence and facility reviews, and manage corrective and preventive actions (CAPAs). The role will collaborate with cross-functional teams and utilize tools in multiple digital platforms, including Foodlogiq, CMX1, and internal Product Lifecycle Management (PLM) tools.

Key job responsibilities
1. Facility Approval & Due Diligence
• New Facility Qualification: Perform the end-to-end qualification of new food production sites for WWGS Private Brands, ensuring all regulatory, hygiene, and safety standards are met before any product is released.
• Ongoing Due Diligence: Maintain and update due diligence documentation for all existing production sites, including audits, certifications, and compliance evidence.
• Risk Assessment: Perform periodic risk assessments to identify potential hazards and develop mitigation strategies.
• Stakeholder Collaboration: Work closely with Procurement, Supply Chain, Product Development, and Quality teams to align food safety requirements with procurement strategies and product launch timelines.

2. Facility Reviews & Inspections
• On-Site Reviews: Conduct comprehensive reviews at risk prioritized production sites to verify adherence to food safety standards, GMPs, and internal policies.
• Audit Leadership: Coordinate and lead internal and third party audits, incorporate findings, and ensure timely implementation of corrective actions.
• Supplier Scorecarding: Maintain a supplier scorecard system that captures performance metrics (e.g., audit results, CAPA closure rates, compliance status) and feeds into supplier selection and renewal decisions.

3. Systems & Tool Proficiency
• Platform Management: Utilize Foodlogiq, CMX1, and internal Product Lifecycle Management (PLM) tools. Ensure all food safety data is accurately entered, maintained, and reported through these systems.
• Data-Driven Decision Making: Pull and analyze data from the platforms to generate insights, dashboards, and trend reports that support strategic decision-making.

4. Corrective & Preventive Actions (CAPA)
• Incident Management: Work closely with the Incident Management team to investigate and close out CAPAs resulting from food safety incidents, non-conformances, or audit findings.
• Root Cause Analysis: Lead root cause investigations, develop effective corrective actions, and verify effectiveness of preventive actions.
• CAPA Tracking: Maintain a centralized CAPA log within the appropriate system, ensuring timely closure and documentation of all actions.

5. Policy, Procedure & Compliance
• Standard Operating Procedures (SOPs): Develop, maintain, and enforce SOPs related to facility qualification, audit planning, and CAPA management.
• Regulatory Compliance: Ensure all activities comply with FDA, FSMA, USDA, and other applicable food safety regulations.

6. Reporting & Communication
• Executive Reporting: Provide regular updates to senior leadership on key metrics (e.g., audit results, CAPA closure rates, supplier performance) through dashboards and written reports.

BASIC QUALIFICATIONS

- Bachelor's degree or equivalent
- 6 - 10+ years of compliance, audit, or risk management experience, preferably within regulated consumer product categories such as Dietary Supplements, OTC Drugs, and/or Cosmetics/Bodycare
- Knowledge of Microsoft Office products and applications at an advanced level
- Experience in operations, investigations, risk management, incident or crisis management, or handling escalations
- Working knowledge of FDA regulations applicable to Dietary Supplements (21 CFR Part 111 – cGMP), OTC Drug products (21 CFR Parts 210/211), and Cosmetics/Bodycare (MoCRA, 21 CFR Part 700 series)
- Familiarity with third-party certification programs such as GRMA, NSF, USP, UL, or NPA for Dietary Supplements, and ISO 22716 (GMP for Cosmetics)
- Experience interpreting and applying FDA warning letters, import alerts, and enforcement actions relevant to Dietary Supplements, OTC Drugs, or Cosmetics/Bodycare
- Familiarity with labeling requirements under DSHEA, OTC Drug monograph system, and FDA cosmetic labeling regulations
- Experience conducting or managing supplier/facility audits and GMP compliance reviews for regulated product manufacturers
- Understanding of pharmaceutical manufacturing validation principles, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment, utilities, and manufacturing processes used in OTC Drug production
- Familiarity with process validation lifecycle (Stage 1: Process Design; Stage 2: Process Qualification; Stage 3: Continued Process Verification) as outlined in FDA’s 2011 Process Validation Guidance
- Knowledge of cleaning validation requirements and acceptance criteria for OTC Drug manufacturing equipment and shared-use facilities
- Understanding of analytical method validation principles (accuracy, precision, specificity, linearity, range, robustness) per ICH Q2(R1) as applied to OTC Drug product testing

PREFERRED QUALIFICATIONS

- Master’s degree or equivalent, preferably in Microbiology, Food Science, Regulatory Affairs, Chemistry, Pharmacy, or a related scientific discipline
- Experience managing Private Brands, with a focus on regulated health, wellness, or personal care product categories
- Professional auditing qualification, or similar risk or compliance credentials (e.g., ASQ CQA, PCQI, RAC)
- Experience reviewing Certificates of Analysis (CoAs), product specifications, and safety assessments for compliance with applicable regulatory standards
- Knowledge of adverse event reporting obligations under DSHEA (serious AERs), OTC Drug regulations, and MoCRA for cosmetics
- Experience developing or evaluating Environmental Monitoring Programs (EMP) and Water Monitoring Programs within regulated manufacturing environments
- Familiarity with international regulatory frameworks including Health Canada (NHP Regulations), EU Cosmetics Regulation (EC No 1223/2009), and TGA requirements for complementary medicines
- Experience reviewing or auditing IQ/OQ/PQ validation protocols and summary reports for manufacturing equipment (e.g., tablet presses, capsule fillers, coating pans, liquid filling lines, HVAC systems, purified water systems) used in OTC Drug manufacturing
- Experience with computer system validation (CSV) principles and 21 CFR Part 11 compliance requirements for electronic records and signatures in pharmaceutical/OTC manufacturing environments
- Knowledge of stability study design and protocols for OTC Drug products, including accelerated and long-term stability testing requirements
- Understanding of blend uniformity, content uniformity, and in-process controls relevant to solid oral dosage form OTC Drug manufacturing

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