Manager, Quality Systems and Risk Management

$95,000 - $105,000/Yr

Cibus 3.0 - Roseville, MN

Full-time - Mid Level

Roseville, MN

Professional, Scientific, and Technical Services

About the position

Cibus is a biotechnology company that specializes in advanced technologies to precisely target and direct a plant's natural gene-editing processes. This innovative approach accelerates natural plant breeding, a practice that has been integral to farming for thousands of years. The company aims to produce sustainable industrial and agricultural products while improving human health by safely harnessing nature's genetic diversity. With a global presence, Cibus operates subsidiaries in Europe and North America, alongside a state-of-the-art research and development center located in San Diego, California, and Roseville, Minnesota. The company has a robust pipeline of traits for canola and rice and is actively developing crop platforms and trait products for other major global crops, including soybean, corn, and wheat. Cibus also has a strain-advancement program that focuses on developing sustainable products in microbial platforms for various markets, including food, flavor and fragrance, and personal care. The Manager of Quality Systems and Risk Management will play a crucial role in leading the planning and implementation of quality systems and risk management across Supply Chain and Operations. This position requires a highly collaborative and cross-functional approach, necessitating strong leadership, organizational, and communication skills to create, implement, and support a robust quality program. The successful candidate will work closely with production and technical teams, as well as senior leaders, to foster and reinforce a culture of quality throughout the organization. This role is pivotal in ensuring compliance with internal and external standards, managing quality issues, and driving continuous improvement initiatives.

Responsibilities

• Onboard and administer Cibus' electronic quality management system and support cross functional teams with CAPA, MOC, and Non-Conformance management, including initiation, follow-up and closing out items on time.
• Support cross functional teams with the investigation of product inquiries and internal quality issues to identify the root causes and recommend/implement corrective and preventative measures to eliminate recurring quality issues.
• Prepare, deliver, and participate in Cibus training initiatives.
• Review documentation, SOPs, reports, and records for internal and external compliance to standards. Ensure SOPs, reports, and records are created, controlled, and reviewed/revised, as required.
• Support the Supplier Quality management program by establishing and maintaining quality requirements, evaluating supplier performance, and participating in supplier audits and reviews, as required.
• Establish a Management Review program and prepare for and facilitate required management review meetings.
• Establish an Equipment Calibration and Maintenance program that includes scheduling, tracking of status, and carrying out repairs or replacements as required. Review and provide input on equipment and process validations ensuring all measuring and testing equipment used in the manufacturing and QC process are calibrated and maintained.
• Establish an audit program and conduct internal audits to ensure compliance with the quality management system, internal and external regulations, and customer requirements. Facilitate and coordinate external audits for certification, ensuring alignment with applicable standards.
• Support functional teams with identifying, analyzing, and mitigating risks in line with enterprise risk management best practices. Maintain a risk register and provide regular updates and reports on the risk profile.
• Enable a culture of continuous improvement by supporting lean initiatives and process improvement projects, with an emphasis on increasing efficiency and reducing timelines and cost.
• Provide reports with the appropriate level of detail and frequency to the Head of Quality Assurance and leadership showing the overall performance, use, and health of our QMS as well as any trends in quality or defects with the goal of mitigating and preventing recurrence and future problems.

Requirements

• Bachelor's degree in agriculture, plant science, quality, or related field.
• 10+ years' experience in agriculture supply chain, seed production, breeding, plant science or related field and 5+ years' experience in a quality assurance role.
• Hands on experience with implementing and managing quality management systems, specifically ISO9001. Working knowledge of ZenQMS is an asset.
• Experience in tracking and mitigating operational and corporate risks.
• Ability to read, write, and understand product specifications, SOPs, work instructions, and customer, regulatory, and legal requirements.
• Exceptional leadership, communication, and interpersonal skills.
• Strong organizational skills with good attention to detail.
• Strong analytical and problem-solving skills to creatively assess processes, gaps and develop recommendations.
• Proficient in SharePoint, Teams, Visio, and the MS Office suite of tools, specifically Excel, Word, and Outlook. Working knowledge of Power BI is a definite asset.
• Excellent time management skills with the ability to work on several projects or issues at the same time.
• Strong sense of enablement with a demonstrated ability to achieve success through direct and indirect reporting responsibilities.
• Leads by example and willing to work side-by-side with reports and peers while using positive strategies to establish a professional environment of trust, respect, and collaboration.
• Capable of achieving success in a dynamic and fast-paced production and technical environment, as well as a strong promoter and implementer of change with the ability to influence at all levels of the organization.