Senior Quality Manager

Job Summary 

MycoWorks is seeking a person to fill the role of Senior Quality Manager. This person will be responsible for leading the Union, SC Quality team, which is constituted of 6 pillars : Site wide Quality Assurance, , Quality Assurance, Technology Documentation System Development & Adherence, Change Management & Continuous Improvement.

The person will be expected to design and manage the quality processes for the site, including internal and  external partners.. The role will require the ability to track and trend performance to plan. This role supports all functions of the organization including Manufacturing and requires a close collaboration with the Process Development  team. The role reports to the VP of Quality. 

Responsibilities:

• Directly manage direct reports respectively responsible for operational quality, , environmental monitoring and biotechnology monitoring, this includes direct mentoring and coaching of all team members
• Define, develop, establish, run, and maintain the Quality functions including: Quality testing, EM, Micro and quality data systems
• Collaborate with leadership on strategies related to quality, the further expansion of the Quality department and laboratory systems
• Prioritize activities and allocate resources in accordance with quality strategy
• Lead the facilitation and coordination of quality suppliers, lab supplies, capital equipment and lab layout and expansion.
• Participate in the supply chain loss allocation process to set standards for savings and simplification processes across the network
• Establish cleanliness standards and protocols to maintain a high level of sanitation throughout the production process
• 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 scoping and prioritization of improvement projects and future implementations, participate in the scoping and quoting of projects
• Lead and prioritize quality based problem solving modeling and related analyses / mathematical modeling of large data sets 
• Troubleshoot quality-related plant issues as they come up and lead an action plan to address the problem

Qualifications:

• BS/MS in quality related fields (Chemistry, Biology, Microbiology)
• At least 10 years’ experience through increasing levels of quality management experience
• At least 5 years’ experience directly managing reports
• Experience across finished product, raw material systems, method development, microbiology and manufacturing based quality with five plus years managing a quality team
• Experience participating in the development of opportunity assessments and loss analysis across the quality function to reduce spend and complexity
• Experience managing vendor relationships and will coordinating work with others, both internally and externally
• Experience completing and maintain yearly vendor evaluations
• Build and execute strategic quality policies, practices, and systems
• Experience developing laboratory planning models for materials, human resources and complex quality release systems required
• Experience in vendor oversight and managing external partnerships and relations
• Professional quality certification a plus: ASQ, ISO, Six Sigma, Certified Manager of Quality certification
• In-depth knowledge / experience with life science environmental monitoring management a plus
• Manage multiple priorities simultaneously, have a strong drive - results focused
• Strong analytical skills and ability to provide data-based insights and observations
• Detail oriented with excellent verbal and written communication skills
• Desire to grow and take on increased scope of responsibility
• Ability to build, train, recruit team members as needed