Regulated and Stewardship Specialist

About the role

The Regulated and Stewardship Specialist oversees quality and stewardship activities for nursery seed production and trialing teams within the North America (NA) region. This role focuses on the compliant handling of stewarded and regulated materials (including GM and GE traits) to ensure field compliance and quality assurance (QA) for effective pipeline delivery.

Responsibilities

• Lead and coordinate new processes, protocols, and site designs to incorporate regulatory, stewardship, and quality control requirements.
• Lead and support MoC (Management of Change) process for regulated/stewarded process changes.
• Care for QA (Quality Assurance) methods in NA Nurseries.
• Provide and present Quality & Stewardship metrics to leaders.
• Lead Quality & Stewardship monthly calls.
• Lead critical investigations and RCA (Root Cause Analysis) for problems related to regulatory, stewardship, and quality.
• Lead yearly Level 2 Regulated & Stewardship Audits & Level 1 assessments.
• Regional SQC lead for North America Region – Seeds Development: Ensure SQC Strategy and Operation is in compliance with Global SQC standards.
• Follow-up SQC results and actions taken to avoid GMI and maintain LTO.
• Assist Trialing and Nursery operations with USDA inspections during preparation and execution.
• Develop training resources for regulated and stewarded key processes within Trialing & Nursery Operations.
• Develop and improve training tools and resources for all QMS regionally.
• Ensure waste streams and destruction processes are followed.
• Manage quality for Regulated and Stewarded trials, including: Document Management, Nonconformity Management, PDCA Audits, Risk Analysis, Incident Response.
• Support Operation teams to ensure regulated seed shipments meet compliance requirements.
• Support Trait Assessment APHIS/NSVBM process review for compliance.
• Support shipping and receiving of NSVBM (Non-Seed Viable Biological Materials including insects, pathogens, nematodes, soil, plants) to meet compliance requirements.
• Support ETS (Excellence Through Stewardship) best practices implementation.

Qualifications

• Bachelor's degree in agriculture, biology or related field or 5+ years’ experience in agricultural operations, preferably in Seed Development, Seed research, Seed Production or plant breeding environments.
• A clear understanding of Quality Management and Stewardship guidelines and practices applicable to nursery seed production.
• A knowledge of Regulated/Stewarded compliance guidelines is required.
• A knowledge of Quality Management and Stewardship methods and systems and Reliance tool (Quality Management System tool).
• Ideal working knowledge of Regulated/Stewarded Field Trials and RegOne (regulatory management system) tool.
• A Continuous Improvement mindset.
• The ability to build relationships, influence and collaborate cross functionally.
• Experience working with Regulated and Stewarded materials and strong interaction with Regulatory team is a plus.