Executive Director, Head of External Quality

About the Company

Pioneering biotechnology (BioTech) company specializing in gene therapy & cell engineering solutions

Industry
Biotechnology

Type
Public Company

Founded
2018

Employees
201-500

Funding
$200 million

Categories

• Biotechnology
• Health Care
• Life Science
• Product Research
• Pharmaceuticals
• Medicine
• Manufacturing
• Chemical Products
• Firms
• Graphic Design

About the Role

The Company is seeking an Executive Director, Head of External Quality to join their dynamic team. The successful candidate will be a strategic leader, driving the execution of the External Quality organization and ensuring the highest standards in the selection, qualification, and oversight of partners, CDMOs, and suppliers. This role demands a professional with a Bachelor's, Master's, or PhD in a pertinent science or engineering field, and a minimum of 15 years of quality oversight experience in the biotech or pharmaceutical industry, with a focus on global regulations and GMP environments. The Executive Director will be responsible for providing quality leadership to meet program timelines and goals, overseeing operational performance, and acting as the senior quality liaison between the company and external partners. Applicants should have a proven track record in quality risk management, decision-making, and the ability to anticipate and proactively address compliance issues. The role also requires the candidate to be an effective communicator, capable of influencing both internal and external stakeholders, and to have a high degree of self-motivation. Experience in all stages of product development, from early clinical to commercial, is essential, with a preference for those who have worked with cell and gene products in an end-to-end supply chain. The ideal candidate will be a champion of quality culture, a great place to work, and will be adept at engaging in crucial conversations to support the growth and development of the team. The role at the company is pivotal in ensuring the quality and safety of the products developed, and the ideal candidate will be passionate about the potential of engineered cells as medicines. They will be expected to lead from every seat, thrive as part of a team, and be committed to making a real difference in the lives of patients.

Hiring Manager Title
Vice President, Head of Quality, Technical Operations

Travel Percent
30%

Functions

• CEO/President
• Non-Profit Management
• Operations
• General Management
• Strategy