Head of Quality (Director or VP based on experience)

The Head of Quality will have the primary responsibility to drive and oversee all compliance and quality activities for my client, including interactions with regulatory agencies. Reporting to the CEO, this individual will work closely with teams across the company to ensure accurate and timely flow of information and requirements in compliance with company standards and GxP procedures. The Head of Quality will also oversee any audits conducted by current or potential clients.

Responsibilities

• Ensure all relevant activities conform with necessary standards and practices for regulatory compliance
• Take a leadership role in facility and system audits at all relevant facilities. Ensure audit results are communicated, findings are monitored, and any appropriate corrective actions are taken in a timely manner
• Effectively map and internally communicate compliance priorities to integrate with development and product roadmaps
• Coordinate with regulatory agencies to ensure compliance and to ensure the company is always at the leading edge of thought leadership in this area
• Influence regulators and customers regarding how the company's 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.
• Communicate quality standards and practices to current and potential clients
• Serve as an external spokesperson for the company across a broad range of audiences: professional, regulatory, and corporate partners.
• Optimize and build a highly effective Quality and Compliance function, including coaching, developing, and retaining talent
  

About You

• You have worked as a Quality professional for a minimum of 15+ years in clinical or commercial bio/pharmaceutical or combination product operations and development
• 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 or combo products industries, 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 supporting 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 the company's internal SME's.
• 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 the company has developed and commercializing. 
  

You might resonate with the culture if ...

• You are intellectually fearless. Stretching yourself well out of your comfort zone across multiple disciplines is more the rule than the exception.
• 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 curious. When first-principles reasoning illuminates a path that diverges from the standard assumptions, you feel compelled to see where it leads. 

About the company: 

My client 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 using my clients platform leverage the remote, automated execution of all standard biology and chemistry experiments in the company's industrial lab facilities, working within a software platform for all stages of research workflows, from experimental design to data analysis.

 

 

Posted On: Wednesday, April 16, 2025