Manager, Quality Systems

Taysha Gene Therapies is a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations. The company was founded in partnership with The University of Texas Southwestern Medical Center, or UT Southwestern, to develop and commercialize transformative gene therapy treatments. Together with UT Southwestern, we are advancing a deep and sustainable product portfolio of gene therapy product candidates. By combining our management team’s proven experience in gene therapy drug development and commercialization with UT Southwestern’s world-class gene therapy research capabilities, we believe we have created a powerful engine to develop transformative therapies to dramatically improve patients’ lives. In addition to our product pipeline candidates, we are building a platform of next-generation technologies to optimize key components of our AAV-based gene therapies, including redosing, transgene regulation and capsid development.

Position: Quality Systems Manager

Reports to: Associate Director, Quality Systems

Office Location: Durham, NC

Overview of Position:

Taysha is looking for a quality systems manager who will support implementation and management of quality systems at Taysha Gene Therapies.

Essential Duties & Responsibilities

• Manage various Quality System programs (i.e. Deviation, CAPA, Change Control, Risk Management, Complaints), including implementing systems and processes to support each program.
• Lead Veeva QMS implementation. Develop and conduct End User Training.
• Develop and deploy training on quality management systems.
• Establish and drive metrics within each Quality System program to measure program effectiveness and ensure appropriate corrective actions are taken to continuously improve quality metrics.
• Lead Change Control Review Boards.
• Develop and implement quality systems metrics to report to Quality Council.
• Present on quality systems programs and provide requested QMS reports during regulatory inspections.
• Identify quality issues and effectively and proactively resolve them in a diplomatic and collaborative manner.
• Develop and maintain Annual Product Review and Site Master File for Durham manufacturing facility.
• Perform other duties as required.

Minimum Qualifications

• Bachelor’s degree in scientific related field.
• Minimum of 7 years’ experience in a quality related role, with at least 3 years’ direct experience in Quality Systems.
• Experience with regulatory inspections as well as strong understanding of change control, deviation, CAPA management and Quality Risk Management.
• Strong knowledge GxP regulations, quality systems and guidance documents.
• Experience with implementing electronic QMS.
• Must have excellent attention to detail, project, and time management skills as well as the ability to manage multiple priorities with aggressive timelines.
• Ability to work with minimal supervision.  
• Good culture fit with Taysha’s Core Values:
  • Audacious: Think Big, Be Courageous
  • Empathy: For each other, For patients
  • Collaborate: Respect each other, explore differences, unite as a team
  • Love: what you do, do what you love

Preferred Qualifications

• Experience with Veeva QMS

The level of this position will be based on the final candidate’s qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Taysha is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Taysha are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.