GxP and Regulatory QA Lead
15 hours ago
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OnsiteFull-timeSenior
Summary
Soley Therapeutics is seeking a GxP and Regulatory QA Lead to join their team in South San Francisco, CA. The role involves overseeing and ensuring quality and compliance of the company's clinical/non-clinical operations related to drug discovery processes.
About the Role
As a GxP and Regulatory QA Lead, you will be responsible for developing and maintaining a Quality Management System (QMS) using the Veeva platform, managing controlled documents, and ensuring compliance with GxP and FDA regulations. You will collaborate with cross-functional teams to resolve quality events, perform quality checks, and support audits and inspections.
About You
Required:
- 7+ years of experience in Quality Assurance/Quality Control roles in drug discovery within life science, pharmaceutical or biotechnology industry.
- 5+ years of experience implementing, administering and maintaining various Veeva Vault modules.
Preferred:
- In-depth understanding of ISO requirements and regulatory requirements for FDA and EMA.
- Strong analytical skills with the ability to analyze data and make recommendations for improvements.
Soley Therapeutics
Soley's mission is to develop safe and effective new drugs for treatment of a broad spectrum of diseases for which there are currently limited treatment options.
South San Francisco, CA