VP of Quality

Job Summary 

MycoWorks is seeking a person to fill the role of VP of Quality. This role is highly strategic and will be responsible for designing and implementing company-wide Quality Testing, Environmental Monitoring, Microbiological and quality data strategies. 

This includes the following: company-wide quality testing strategies including strategic lab management, quality systems management, methods management, external laboratory contractor management, quality personnel management as well as developing quality managers and staff; company-wide environmental management strategies including strategic planning across multiple sites and countries, testing and assessment, implementation of contractors and suppliers to support as well as developing EM managers and staff; company-wide microbiological strategies including raw materials, in-process materials, finished goods and developing microbiological managers and staff. 

The person will be expected to design and manage the quality processes across the organization, including external partners, as well as working directly with customers to set customer needs, develop in-house customer based methods and issue compliance tracking and data analysis. The role will require setting appropriate metrics to track and trend performance to plan. 

This role supports all functions of the organization including both commercial and R&D. The role reports to the Chief Operating Officer. 

Responsibilities: 

• Define, develop, establish, run, and maintain the company’s quality system, including BOM, Raw Material, Data Tracking, MES Data Analysis, and other related processes
• Drive top-down support for MycoWorks facilities to ensure implementation and maintenance of Quality Management throughout the organization
• Strategically develop quality systems and standards for manufacturing facilities in Emeryville, CA and Union, SC. 
• Provide input and direction to all supporting groups such as Technology Development, Manufacturing, Engineering, and Supply Chain as needed
• Communicate all critical and relevant quality issues to MycoWorks’ executive leadership team and provide recommendations for remediations and corrective actions, as well as for best practices
• Areas of responsibility include: Environmental Monitoring, Biological/Infection Monitoring and Development, Crust Quality, In Process Measures, Raw Material Testing and Method Development, Cleaning and Gowning Protocols, BOM Release and QC Release to customers, Issuing CoA to Tanneries and Customers
• Work closely with Tannery Management team in EU on quality system strategy and implementation
• Recruit, train, and grow members as needed - including managers, analysts, quality technicians, suppliers and outside capability partners 
• Lead the facilitation and coordination of quality suppliers, lab supplies, capital equipment and lab layout for all sites, including external partners
• Lead the development of lean lab systems implementation including developing a complete lab visualization tool that incorporates downstream partners, current sites and starting materials. 
• Participate in the supply chain loss allocation process to set standards for savings and simplification processes across the network 
• Lead development of a risk management based approach to standards and systems development,support contracts and agreements and sourcing 
• Lead establishment of supplier qualification process and manages and assess vendor’s performance and reports operational metrics (KPIs) to senior management, as well as any regulatory reporting requirements related to production and quality activities 
• Lead and prioritize quality based problem solving modeling and related analyses / mathematical modeling of large data sets 
• Lead scoping and prioritization of improvement projects and future implementations, participate in the scoping and quoting of projects 

Qualifications: 

• BS/MS in Quality or quality related fields (Chemistry, Biology, Microbiology) 
• 15+ years’ experience through increasing levels of quality management
• At least 5+ years of experience working at the corporate level, developing organizational strategies
• Experience across finished product, raw material systems, method development, microbiology and manufacturing based quality with seven plus years managing a quality team 
• Experience building and maintaining contamination prevention programs for biological systems
• Experience participating in the development of opportunity assessments and loss analysis across the quality function to reduce spend and complexity 
• Experience managing a large multi-functional team across regions 
• Experience with multi-site operations required, international experience preferred
• Experience with biomaterials and leather alternatives a plus
• Experience developing laboratory planning models for materials, human resources and complex multi-site quality release systems required 
• Experience in vendor oversight and managing external partnerships and relations 
• Professional quality certification a plus, i.e. ASQ, ISO, Six Sigma, Certified Manager of Quality certification 
• In-depth knowledge and experience with life science environmental monitoring management 
• Ability to manage multiple priorities simultaneously, results-focused
• Strong analytical skills and ability to provide data-based insights and observations 
• Ability to build, train, recruit team members at all levels as needed, including Manager, Senior Manager and Director
• Ability to travel, domestically and internationally, up to 25%

We are a 24/7 manufacturing operation. This role may require overtime and the ability to work varied shifts in order to meet the needs of the business.