Director of Quality Assurance
ConfidentialSeattle, WA, United States- Full-time
Director of Quality Assurance
About the Company
Join an innovative biotech firm at the forefront of developing selective monoclonal antibodies targeting 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
We are looking for a dynamic Director of Quality Assurance to spearhead the development and implementation of a robust QA strategy. In this critical leadership position, you will build and lead a QA team focused on ensuring global GMP and GLP compliance throughout the development, manufacturing, and regulatory approval phases of our innovative products. Your expertise will be vital in maintaining the company’s inspection readiness and will require a comprehensive understanding of QA processes, particularly for combination product drug delivery systems.
As the Director, you will collaborate closely with cross-functional teams to meet global regulatory requirements, fostering a culture of quality and continuous improvement within the organization. A Bachelor’s or Master’s degree in a relevant field, coupled with a proven track record in progressive QA leadership within the biotech or pharmaceutical industry, is required. Experience in combination product development is essential, along with in-depth knowledge of GMP regulations, device-specific standards, and quality systems.
This role demands a collaborative leader with strong influencing and project management skills, capable of effectively representing QA in governance forums and during health authority inspections. You should also possess experience in risk management, design quality activities, and navigating the complexities of pre-commercial biotech environments. Our ideal candidate is results-oriented, forward-thinking, and adept at managing multiple projects while driving a culture of accountability and cooperation.
Hiring Manager Title
VP, Head of Quality
Travel Percent
20%
Functions
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