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.
Position: Director, Quality Compliance and Quality Assurance Validation (QAV)
Overview of Position
The Director, Quality Compliance and QAV will provide daily QA oversight of GxP Suppliers, ensure Taysha inspection readiness, and provide quality oversight of technical transfer and PPQ operations at Taysha’s contract manufacturing operations (CMO).
Essential Duties & Responsibilities
Responsible for building a first-class compliance organization implementing the Quality Compliance program, systems and procedures including:
Establishes and Leads the Internal and External Auditing Program
Schedule and track audits in accordance to the approved audit plan
Supplier Management Program
Establish Inspection Readiness program.
Manage and Lead GxP Regulatory Inspections
Plans and leads regulatory agency inspections.
Oversee and manage all GxP Quality Agreements
Provide quality input for technical transfer, process characterization, process validation and continued process verification deliverables
Foster a quality mind-set within Quality and throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions.
Drive review and closure of CMO PPQ process related deviations, CAPAs and change controls ensuring appropriate escalation and notification to leadership as applicable.
Partner with management, internal departments, third parties and other sites to provide effective QA oversight and guidance.
Travel to external manufacturing sites anticipated at 20-30%
Minimum Qualifications
Bachelors’ degree in Life Sciences.
Minimum of ten (10) years industry experience, ideally with early clinical phases through commercial drug product.
Direct experience working with CMOs to meet product disposition timelines.
Thorough knowledge of cGMPs, ICH and global regulatory requirements.
Strong management experience to lead cross-functional teams to effectively resolve quality issues.
Excellent written and verbal communication skills
Preferred Qualifications
Experience with gene therapy products.
Previous experience in start-up environment.
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.
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