Director of Quality

The Director of Quality will partner with a cross functional leadership team to drive compliance and quality activities for Emerald Cloud Lab (ECL). Reporting to ECL’s Head of Quality, this individual will provide on-site Quality leadership from both a compliance and continuous improvement perspective. The Director of Quality will assist the Head of Quality with audits conducted by current or potential clients.

Responsibilities

• Ensure all relevant activities at ECL conform with necessary standards and practices for regulatory compliance
• Take a leadership role on site in the Austin facility providing direct supervision to a team of 3-10 Quality staff (on site and remote)
• Ensure audit results are communicated, findings are monitored, and any appropriate corrective actions are taken in a timely manner
• Influence regulators and customers regarding how ECL technology and practices map to existing regulatory frameworks and terminology, particularly with respect to automated data capture, data verification, software validation, and software encoded SOPs.

About You

• You have worked as a Quality professional for a minimum of 10-15 years in pharmaceutical operations. With a minimum of 3 years at the director level or above
• You have demonstrated experience providing direct leadership to a Quality team including both exempt and non-exempt workers.
• You have advanced knowledge of Quality principles, concepts, industry practices and standards
• You have strong proven hands-on experiences with GxP compliance matters in the bio/pharma industry, including both software development and laboratory operations
• You are able to interpret 21 CFR Part 11 and GxP quality principles for novel technologies
• You have experience with the regulatory submission and approval process
• You have experience building Quality systems for all phases of development and deployment
• You are familiar and comfortable with agile software development principles
• You have an understanding of scientific methods and the ability to interpret and communicate scientific data internally and externally
• You are comfortable reading into and becoming familiar with the technical details of the product with the assistance of ECL’s team
• You are able to inspire confidence in ECL’s product
• You are able to multitask in a fast-moving environment
• You are resourceful in setting priorities
• You have outstanding oral and written communication skills
• The mission of the company resonates with you and you are passionate about the unprecedented potential of the technology that Emerald is developing

You might resonate with the culture at ECL if ...

• You are passionate about science, technology, and medicine.
• You are impressively empathetic. You can argue the rationale you disagree with as convincingly as the one you agree with.
• You are intellectually fearless. Stretching yourself well out of your comfort zone across multiple disciplines is more the rule than the exception at Emerald.
• You are curious. When first-principles reasoning illuminates a path that diverges from the standard assumptions, you feel compelled to see where it leads.

About ECL

www.emeraldcloudlab.com

The Emerald Cloud Laboratory (ECL) enables life scientists to move out of the lab, and to conduct research entirely from a computer. Stepping away from manual completion of experiments at the bench, scientists on the ECL leverage the remote, automated execution of all standard biology and chemistry experiments in Emerald’s industrial lab facilities, working within a software platform for all stages of research workflows, from experimental design to data analysis.