Confidential
Vice President of Quality
About the Company
Innovative gene therapy company
Industry Pharmaceuticals
Type Privately Held
Founded 2019
Employees 51-200
Categories
Pharmaceuticals Biotechnology Health Care Academic Research Medical Devices Genomics Medical Conditions Medicine Manufacturing Chemical Products
Specialties
gene therapy rare diseases aav vector capsid research biotechnology teamwork integrity passion and discovery
About the Role
The Company is seeking a Senior Director/Vice President of Quality to lead the quality function and ensure the highest standards of quality and compliance in the development of transformative gene therapies. The successful candidate will be responsible for quality oversight in all GxP functional areas, from discovery through clinical development to launch readiness. This includes leading quality control activities related to the testing and release of products, as well as ensuring compliance with GxP processes and health authority guidance in preclinical and clinical studies. The role also involves providing strategic direction for the implementation of global quality standards and procedures, managing quality issues, and leading internal and regulatory inspections.
Applicants must have a degree in life sciences, engineering, or a related discipline, with a minimum of 15 years of work experience, and at least 10 years in management positions within quality assurance, preferably in the biotech industry. The role requires in-depth knowledge of FDA, EU, and international regulations, as well as experience in AAV viral vector manufacturing. The ideal candidate will have a proven track record in building and leading successful quality organizations, a hands-on approach, and the ability to set and execute quality strategies. Strong leadership, organizational, and interpersonal skills are essential, as is the ability to work effectively in a dynamic, cross-functional team environment.
Hiring Manager Title Chief Medical Officer
Travel Percent Less than 10%
Functions
General Management Operations Strategy
About the Company
Innovative gene therapy company
Industry Pharmaceuticals
Type Privately Held
Founded 2019
Employees 51-200
Categories
Pharmaceuticals Biotechnology Health Care Academic Research Medical Devices Genomics Medical Conditions Medicine Manufacturing Chemical Products
Specialties
gene therapy rare diseases aav vector capsid research biotechnology teamwork integrity passion and discovery
About the Role
The Company is seeking a Senior Director/Vice President of Quality to lead the quality function and ensure the highest standards of quality and compliance in the development of transformative gene therapies. The successful candidate will be responsible for quality oversight in all GxP functional areas, from discovery through clinical development to launch readiness. This includes leading quality control activities related to the testing and release of products, as well as ensuring compliance with GxP processes and health authority guidance in preclinical and clinical studies. The role also involves providing strategic direction for the implementation of global quality standards and procedures, managing quality issues, and leading internal and regulatory inspections.
Applicants must have a degree in life sciences, engineering, or a related discipline, with a minimum of 15 years of work experience, and at least 10 years in management positions within quality assurance, preferably in the biotech industry. The role requires in-depth knowledge of FDA, EU, and international regulations, as well as experience in AAV viral vector manufacturing. The ideal candidate will have a proven track record in building and leading successful quality organizations, a hands-on approach, and the ability to set and execute quality strategies. Strong leadership, organizational, and interpersonal skills are essential, as is the ability to work effectively in a dynamic, cross-functional team environment.
Hiring Manager Title Chief Medical Officer
Travel Percent Less than 10%
Functions
General Management Operations Strategy