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Location: - (St. Louis, Missouri, Mid-West United States, USA)
Open Til: 05-Apr-12
Industry Sector: Agribusiness
Industry Type: Crop Protection/Chemicals
Career Type: Researcher/Scientist
Job Type: Full Time
Minimum Years Experience Required: N/A
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The Chemistry Compliance Manager role within the Regulatory Stewardship Field Compliance Team is primarily responsible for the design, management, and execution of Monsanto#39;s field compliance program for Chemistry products across the US. The Chemistry Compliance Manager will work with Monsanto#39;s cross functional teams to secure required approvals to conduct confined field trials for Chemistry pipeline products. In addition, the role will work with members of the Field Compliance and Regulatory Affairs teams to support required reporting requirements for field trials to regulatory agencies. To facilitate these reporting requirements, the Compliance Manager will develop a data reporting strategy, leveraging existing IT systems for field compliance where possible.
This role will provide compliance support and leadership to the cross-functional US Compliance Committee and other teams to establish and implement procedures and policies to optimize Monsanto#39;s field trial programs for chemistry products. Other initial focus areas include establishing predictable operational models for data reporting requirements and taking ownership of compliance training for internal and external field researchers.
Excellent project management, communication and influence skills are required to work across functions to achieve desired results.
Responsibilities include (but are not limited to):
- The incumbent will work across Breeding, Biotechnology, Regulatory, Manufacturing, Commercial and Chemistry divisions to secure required approvals and to manage seasonal reporting requirements to regulatory authorities.
- The incumbent will provide Compliance support and leadership to the cross-functional US Compliance Committee to establish and implement procedures and policies related to optimize field compliance for chemistry products.
- With a focus on process efficiency and improvement, the Chemistry Compliance Manager will lead Compliance IT system strategy efforts to optimize current systems and evaluate and implement required steps to meet future strategies.
- Excellent project management, communication and influence skills are required to work across functions to achieve desired results.
- Develop strategy and plans to drive integration of Chemistry field compliance needs into Monsanto Confined Field Trial compliance systems and strategies, where applicable.
- Develop and implement procedures, audit checklists, training and other processes to make continuous improvements to the Chemistry Compliance program
- Develop and manage compliance training, outreach and awareness
- Bachelors or Masters with at least 5 years work experience or Ph.D. with at least 3 years work experience in a scientific or technical discipline (Agronomy, Biology, Biochemistry, etc.)
- Knowledge of US regulations specifying chemistry compliance, field trial compliance and/or general knowledge of related industry standards
- Experience developing and implementing quality management and compliance programs and audit systems within and across functions and organizations, preferably in a plant biotechnology environment
- Experience developing successful cross-functional project strategies, plans and leading implementation through networks and teams
- Excellent oral and written communication skills and the ability to adapt communication style and content to influence leadership and facilitate interaction with a diverse audience.
- Must be able to gather and interpret relevant technical information in order to present conclusions in a clear and concise manner.
- Must be highly motivated, flexible, and able to adapt to a fast-paced, dynamic work environment.
- Experience developing, managing and overseeing regulatory product requirements.
- Risk based process improvement knowledge and experience, including application of six sigma, HACCP, LEAN type methodologies to develop quality systems and continuous improvement programs
- Strong technical background and experience with biotechnology and agricultural products through various stages of the product life cycle.
- Basic knowledge of FCM Compliance IT System preferred
- Experience developing or managing quality management systems, such as ISO 9001 or GxPs. Quality auditing experience and/or experience developing audit programs.
- 2+ years experience plant biotechnology field trial experience in a regulated environment