Head of Quality

ShapeTX is seeking a highly skilled and experienced Quality leader to join as their Head of Quality. Reporting to the COO, this role will be responsible for building and managing the Quality function to ensure compliance with company quality policies, SOPs, and federal regulations. The Head of Quality will collaborate with various departments to advance new programmable RNA therapies and oversee a critical area as ShapeTX transitions from a Research-stage to a Clinical-stage company. The successful candidate will design and implement Quality programs, lead inspections by regulatory agencies, and work with external suppliers to ensure consistent quality and compliance.

• Design, implement, and maintain (GxP) Quality programs and compliance infrastructure
• Build and lead high functioning Quality teams
• Ensure timely and accurate completion of Quality activities, including documentation and record keeping
• Lead and manage inspections by regulatory agencies and commercial partners
• Properly document and resolve deviations, investigations, and corrective actions
• Coordinate with regulatory agencies and external auditors to build trust and confidence in company quality systems
• Lead quality input on contracts and negotiate quality agreements
• Ensure consistent quality and compliance with external suppliers
• Direct development and implementation of quality systems to ensure product reliability, quality, efficacy, and compliance
• Oversee the GxP compliance auditing program
• Monitor and analyze quality metrics to identify areas for improvement and implement corrective actions
• Build a culture of quality and focus the organization on highest priorities

• Design, implement, and maintain (GxP) Quality programs and compliance infrastructure
• Build and lead high functioning Quality teams
• Ensure timely and accurate completion of Quality activities, including documentation and record keeping
• Lead and manage inspections by regulatory agencies and commercial partners
• Properly document and resolve deviations, investigations, and corrective actions
• Coordinate with regulatory agencies and external auditors
• Lead quality input on contracts and negotiate quality agreements
• Ensure consistent quality and compliance with external suppliers
• Direct development and implementation of quality systems for product reliability, quality, efficacy, and compliance
• Oversee GxP compliance auditing program
• Monitor and analyze quality metrics for improvement and implement corrective actions
• Build a culture of quality and focus on highest priorities
• Bachelor's degree in science-related field
• 12+ years of experience

• Medical, Dental, and Vision coverage for employees and their eligible dependents
• 12 paid Holidays plus a one week winter break at year end
• Competitive paid parental leave benefit
• Annual employee stipend for employees to use however they choose
• Flex Paid Time Off program for vacation, sick leave, and other purposes
• Company paid Long Term Disability
• Eligibility to enroll in the Company's voluntary 401k plan, voluntary Life/AD&D, and Voluntary FSA's
• Salary range of $184,000 - $276,000
• Additional compensation may include annual target bonus and/or sign-on bonus, equity grant, and relocation bonus
• Inclusive environment that supports diverse perspectives and experiences