Risk Manager III,Body,Dietary Supplements,OTC Drugs,and Bodycare Job Austin area,Texas USA,Quality Assurance

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

Description

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

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.

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 Score carding:
Maintain a supplier scorecard system that captures performance metrics and feeds into supplier selection and renewal decisions.

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.

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.

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.

Reporting & Communication

Executive Reporting:
Provide regular updates to senior leadership on key metrics 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…

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