Senior Director of Quality Assurance
ConfidentialBoston, MA, United States- Full-time
Senior Director of Quality Assurance
About the Company
Innovative biotech company focused on developing selective monoclonal antibodies tailored 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 on the lookout for a Senior Director of Quality Assurance to spearhead the development and execution of a robust QA strategy. In this crucial role, you will be responsible for assembling and guiding a QA team dedicated to ensuring global GMP and GLP compliance throughout the development, manufacturing, and regulatory approval phases of our products. Your expertise is vital in maintaining the company’s inspection readiness, especially concerning combination product drug delivery systems.
As a key player, you will collaborate with cross-functional teams to align with global regulatory requirements while fostering a culture of quality and continuous improvement within the organization. Ideal candidates will possess a BS or MS degree in a relevant field, along with a proven history of progressive QA leadership within the biotech or pharmaceutical sectors, particularly in combination product development.
A solid understanding of GMP regulations, device-specific standards, and quality systems is non-negotiable. We seek a dynamic leader with exceptional collaboration, influencing, and project management skills who can effectively advocate for QA in governance discussions and during health authority inspections. Experience in risk management, design quality activities, and pre-commercial biotech environments is crucial. The successful candidate will be results-oriented, bring a forward-thinking approach, and thrive in managing multiple projects while cultivating a culture of quality, accountability, and teamwork.
Hiring Manager Title
VP, Head of Quality
Travel Percent
20%
Functions
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