Title: Director of Quality Assurance
Summary: A biotech startup is currently seeking a driven and motivated Director of Quality Assurance to lead their headquarters in Pennsylvania. As the Management Representative, you will be responsible for developing Quality Systems to ensure their combination product meets the established standards of quality.
The Director of Quality Assurance will be responsible for…
- Developing a high performing Quality Assurance team
- Managing the Supplier Quality program
- Identifying training needs and ensure cGMP training for all employees
- Coordinating and hosting audits, FDA inspections, and ISO 13485 audits
- Assuring ongoing compliance with quality and industry regulatory requirements
The Director of Quality Assurance should have the following qualifications:
- Bachelor's degree in Life Sciences or Engineering
- 5+ years of experience in Quality
- Detailed knowledge of ISO 13485, GMP, and FDA regulations
- Leadership background
- Preferred: Advanced degree and implementation of Quality Systems for a startup company
If you're interested in this Director of Quality Assurance role, then please don't wait to apply!