Senior Quality Assurance Director, Regulatory Affairs

6 days ago


Brisbane, Queensland, Australia Vera Therapeutics, Inc Full time

Vera Therapeutics, Inc is a leading biotechnology company focused on developing treatments for serious immunological diseases.

We are seeking an experienced Senior Quality Assurance Director, Regulatory Affairs to join our team.

This role will be responsible for developing and maintaining GMP, GLP and GCP Quality Management Systems in accordance with FDA, ICH, EMA regulations and guidelines and industry standards.

The successful candidate will have a strong background in quality assurance and regulatory affairs, with experience in establishing and implementing quality systems.

They will also have excellent leadership and communication skills, with the ability to work collaboratively with cross-functional teams.

In this role, you will be responsible for:

  • Developing and maintaining quality management systems
  • Ensuring compliance with regulatory requirements
  • Providing leadership and guidance to the organization on global quality matters
  • Managing the investigation and resolution of out of specifications and deviations

We offer a competitive salary range of $170,000 - $208,000, depending on qualifications and experience.

In addition to base pay, the successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.

We also offer various benefits, including medical, dental, and vision insurance, 401k match, flexible time off, and paid holidays.



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