Genective VP of Quality Management and Compliance
Genective, a JV between two leading global seed companies, Limagrain and KWS, is seeking a strategic yet hands-on, result-oriented, and stakeholder savvy VP of Quality Management & Compliance to join our fast-growing team in the U.S. and to provide enterprise-wide leadership and oversight for quality, stewardship, and regulatory compliance. This position reports to the President & CEO and is a member of Genective’s Executive Leadership Team (ELT). The primary working location is Champaign, IL, with flexibility for other locations within reasonable commuting distance. Domestic and international travel may be required from time to time.
As a direct report to the President and CEO, the VP of Quality Management & Compliance is the top leader to ensure Genective operation is under sound quality management and in full compliance with all applicable regulations.
Quality management: establish an enterprise Quality Management System (QMS) for Genective to ensure quality and efficiency of R&D and Enabling activities:
- Identify applicable regulations for R&D and Enabling activities to guide policies and processes
- Establish policies, processes, and KPIs and lead implementation across the enterprise
- Identify system needs (IT infrastructure, IT tools, data collection and subscription, etc.); Leverage existing system resources, and lead sourcing for additional resources if need, to ensure system readiness
- Monitor quality results, conduct audits, request corrective actions, and ensure effective and timely corrections
- Serve as the Genective representative at Excellence Through Stewardship (ETS)
- Establish GMO stewardship polices, processes, and KPIs, within the QMS, and lead implementation across the enterprise
- Lead Genective towards successful ETS re-certifications, with the next one required in 2024
- Ensure adoption and effectiveness of GMO stewardship throughout the entire operation of Genective and throughout the full life cycle of Genective products
Regulatory (immediate focus):
- Keep up to date with the latest in regulatory legislation and guidelines in key GMO markets
- Ensure full Regulatory Compliance throughout the entire operation of Genective
- Participate in Genective Research pipeline and portfolio reviews and establish timelines for Regulatory Science and Regulatory Affairs activities accordingly
- Ensure data for future Regulatory Science and Regulatory Affairs needs are captured according to regulatory requirements
Regulatory (future responsibility expansion with proven success in job and demonstrated growth or experience when join Genective):
- Establish Regulatory Science and Regulatory Affairs capabilities for Genective as per timelines established
- Lead de-regulation activities for target markets as per timelines established
- Leads Genective’s workplace safety and employee health process and communication
- Advocates and disseminates the mind-set and practice of “it’s everyone’s job to ensure quality and 100% compliance in everything we do”
- Liaises with and maintains a strong relationship with counterparts at parent companies and AgReliant for alignment needed
- As requested by the President & CEO
The ideal candidate will possess the following qualifications:
- Proven record of success establishing, implanting, or significantly improving a Quality Management System (QMS) in biotechnology, preferably plant biotechnology, or crop protection companies. This may include BQMS, ETS, GLP, or ISO type systems. Understanding of the audit process also very important
- Expert in setting up and maintaining stewardship principles based on ETS accreditation or similar program
- Proven record of success managing Regulatory Compliance parameters of a Biotech Product; expert in USDA, FDA, and EPA regulations for production, storage, movement, and environmental release of regulated material produced through biotechnology
- Expert knowledge of core technical functions needed for data creation that goes into regulatory submissions (USDA, FDA, EPA; global) for transgenic traits
- Understanding of regulatory dossier creation, submittal, registration, and effective communication with global Regulatory Agencies
- A strategic thinker, capable of effectively contributing to establish/communicate clear vision and strategy with measurable goals, balanced with attention to critical details and capability to drive execution and deliver results in an entrepreneurial environment
- Open minded and capable of integrating business aspects, scientific aspects, non-scientific aspects (R&D related legal, IP, regulatory, quality management) and infrastructure / operational aspects into decision processes
- High degree of influencing leadership skills in an international setting among diverse cultures
- Excellent communication skills and able to adjust communication style to highly different audiences
- Willing and able to take feedback in a positive manner as you will be challenged. Humility is critical
- Excellent project management skills and the ability to manage working teams effectively without direct authorities
- MS or PhD in a relevant discipline such as Biological Sciences, Ag Sciences, Biochemistry, or other
- Certifications associated with BQMS, ETS, GLP, ISO
- Ag Biotech compliance training – training to other stakeholders both internal and external
Competitive base salary, bonus, 401(K), medical, dental, vision, FSA for health care and dependent care, short-term disability, long-term disability, basic and voluntary life insurance and AD&D insurance plans, EAP, paid holiday, sick time, vacation, and parental leave, as well as support programs for company car, fitness, education, and employee referral. Plus, fun and satisfaction working in a high trust, high empowerment, high impact, entrepreneurial environment with a close-knit team. Plus, a path to become Chief Compliance Officer with proven success in the job and demonstrated growth to manage Regulatory Science and Regulatory Affairs when established.
Genective is a 50/50 joint venture established between Limagrain and KWS, two of the world’s largest seed companies. With entities and activities in North America, South America, Europe, and Asia, Genective is currently dedicated to the research, development, and commercialization of transgenic traits for corn.
As the fourth largest seed company worldwide, Limagrain’s mission is to move agriculture forward to meet global food related challenges. Limagrain is a cooperative group founded and managed by French farmers. Its parent company, Coopérative Limagrain, brings together nearly 2,000 farmers located in the center of France. The Group creates, produces and distributes field seeds, vegetable seeds and cereal products. Limagrain is present in 56 countries and has more than 10,000 employees. It makes nearly 2.5 billion Euros of sales with recognized brands on their markets: LG, Vilmorin, Hazera, Harris Moran, Jacquet, Brossard.
KWS is one of the world’s leading plant breeding companies. In the fiscal year 2017/18 more than 5,000 employees in 70 countries generated net sales of EUR 1,068 million and earnings before interest and taxes (EBIT) of EUR 133 million. A company with a tradition of family ownership, KWS has operated independently for more than 160 years. It focuses on plant breeding and the production and sale of seed for corn, sugarbeet, cereals, rapeseed, sunflowers and vegetables. KWS uses leading-edge plant breeding methods to increase farmers’ yields and to improve resistance to diseases, pests and abiotic stress. To that end, the company invested approximately EUR 200 million last fiscal year in research and development.
HOW TO APPLY
If interested, please send your cover letter and resume to firstname.lastname@example.org.