Associate Director, Quality Medical Devices

2 weeks ago

Roseville MN, United States Cibus Full time

Associate Director, Quality AssuranceLocation: Agriculture product development, ISO9001, quality management systems, product quality, product and trait stewardship, data analysis and reportingJob Code: QA2416 DESCRIPTION:Cibus is a biotechnology company with advanced technologies to precisely target and direct a plant's natural gene-editing processes. This approach accelerates natural plant breeding that has been a staple of farming for thousands of years and has resulted in a rapid, versatile, and low-cost way to produce sustainable industrial and agricultural products and improve human health by safely harnessing nature s own genetic diversity.
The company has a worldwide presence, with subsidiaries in Europe and North America and a state-of-the-art research and development center in San Diego. Cibus has a pipeline of traits for canola and rice and is developing crop platforms and a pipeline of trait products in other major global crops including soybean, corn, and wheat. The broad applicability of Cibus' technologies is highlighted by the company's strain-advancement program, which develops sustainable products in microbial platforms for the food, flavor and fragrance, and personal care markets.
Cibus has an immediate opening for Associate Director of Quality Assurance. We are seeking an experienced quality professional to lead the quality assurance function. The successful applicant will work closely with our production and technical teams as well as senior leaders across the organization.
This is a highly collaborative and cross-functional role with direct oversight of the three pillars of our quality assurance program: quality systems and risk management, product line quality, and stewardship and compliance. The successful candidate will work with quality leadership to develop and execute the short and long-term strategy of the quality assurance function.
This role plays a key part in representing Cibus to external customers, including global regulatory agencies.Cibus is a biotechnology company with advanced technologies to precisely target and direct a plant's natural gene-editing processes. This approach accelerates natural plant breeding that has been a staple of farming for thousands of years and has resulted in a rapid, versatile, and low-cost way to produce sustainable industrial and agricultural products and improve human health by safely harnessing nature s own genetic diversity.
The company has a worldwide presence, with subsidiaries in Europe and North America and a state-of-the-art research and development center in San Diego. Cibus has a pipeline of traits for canola and rice and is developing crop platforms and a pipeline of trait products in other major global crops including soybean, corn, and wheat. The broad applicability of Cibus' technologies is highlighted by the company's strain-advancement program, which develops sustainable products in microbial platforms for the food, flavor and fragrance, and personal care markets.
Responsible for coordinating and leading the quality assurance function, with direct oversight of quality systems and risk management, product line quality and stewardship and compliance.Contribute to and deliver on the quality function's strategic plan and annual OKRs and communicate across the business.Monitor business and quality KPIs to identify trends and recommend opportunities for improvement.
Foster a culture of quality, risk management, and continuous improvement across the organization.Lead product quality efforts by creating and incorporating quality procedures, standards, and specifications to enable timely product delivery to customers. Partner with QC, production, and product development teams and lead the quality review process across the production pipeline.
Facilitate frequent review meetings for all commercial product lines ensuring they meet specifications and manage the exception process.Create and manage quality reports and dashboards to provide real-time visibility into product quality and supply to enable accurate planning and forecasting.
Responsible for providing reports with the appropriate level of detail and frequency to the Quality Leadership and executives using data analysis and reporting tools to influence organizational decisions through communicating timely and accurate information. This includes customer feedback, product inquiries, assessing quality trends and KPIs to assess and implement opportunities for improvement.Support consistency in quality methodologies, processes, and procedures across commercial production activities.
Evolve and sustain the quality culture where quality is clearly understood and recognized as a driver to improve both the customer experience and business performance.Maintain awareness and understanding of key quality trends and expectations in the agricultural product space and related industries, as well as external quality institutions, to ensure that quality innovations are identified, evaluated, and implemented proactively. Qualifications:Master's degree or bachelor's degree in agriculture, Agronomy, Supply Chain or Biology (Agriculture is preferred) with 3-5 years or 10+ years' experience, respectively.
Strong understanding of quality management systems (ISO9001) and regulatory principles with broad experience in implementing and managing a quality program across an organization, with line management experience.Demonstrated ability to lead and manage teams of direct and indirect reports to achieve technical and professional growth success.Ability to develop and implement quality processes and programs by working with stakeholders and functional leaders.
Knowledge of NetSuite, Power BI, and ZenQMS is a definite advantage.
Remote or hybrid work options are available.If remote, 10-20% travel anticipated. Cibus provides an attractive compensation and benefits package that includes medical/dental/vision, flexible spending, 401(k) plan, vacation and sick leave.

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