Executive Director, Quality Assurance
ConfidentialBoston, MA, United States- Full-time
Executive Director, Quality Assurance
About the Company
Innovative biotech company developing selective monoclonal antibodies for rare autoimmune diseases
Industry
Pharmaceuticals
Type
Public Company
Employees
11-50
Categories
- Pharmaceuticals
- Health Care
- Academic Research
- Biotechnology
- Medical Care
- Medical Conditions
- Medicines
- Manufacturing
- Medicine
- Chemical Products
About the Role
The Company is seeking an Executive Director for Quality Assurance to lead the development and execution of a comprehensive QA strategy. The successful candidate will be responsible for building and leading a QA team to ensure global GMP and GLP compliance in the development, manufacturing, and regulatory approval of the company's products. This role is pivotal in maintaining the company's inspection readiness and requires a deep understanding of QA processes, particularly in the context of combination product drug delivery systems. The Executive Director will work closely with cross-functional teams to meet global regulatory requirements and will be integral in supporting the company's quality culture and continuous improvement initiatives. Candidates for this role at the company should have a BS or MS degree in a relevant field and a proven track record of progressive QA leadership in the biotech or pharma industry, with specific experience in combination product development. Deep knowledge of GMP regulations, device-specific standards, and quality systems is essential. The role demands a leader with strong collaboration, influencing, and project management skills, who can effectively represent QA in governance forums and during health authority inspections. Experience in risk management, design quality activities, and pre-commercial biotech environments is also required. The ideal candidate will be a results-oriented individual with a forward-thinking mindset, capable of managing multiple projects and driving a culture of quality, accountability, and collaboration.
Hiring Manager Title
VP, Head of Quality
Travel Percent
20%
Functions
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