Senior GxP & Regulatory QA Lead – QMS & Audits

Soley Therapeutics; South San Francisco (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading biotech company is seeking a self-motivated GxP and Regulatory QA Lead to oversee compliance within clinical and non-clinical operations. The role requires at least 7 years of relevant experience in Quality Assurance within the pharmaceutical or biotechnology industry, alongside skills in Veeva platform management. Candidates should possess strong analytical abilities and a keen attention to detail. This full-time position supports innovative drug development processes and offers the opportunity to contribute to life-changing treatments.

Qualifications

• 7+ years of experience in Quality Assurance/Quality Control roles in drug discovery.
• 5+ years of experience with Veeva Vault modules.
• In-depth understanding of ISO and FDA requirements.

Responsibilities

• Oversee quality and compliance of clinical/non-clinical operations.
• Develop and maintain a Quality Management System.
• Collaborate with cross-functional teams on quality events.

Skills

Quality Assurance

Regulatory Compliance

Veeva Platform Management

GxP Knowledge

Analytical Skills

Documentation Accuracy

Team Collaboration

Education

Bachelor’s or advanced degree in Science or Engineering

Tools

Veeva Vault modules

Microsoft Office

Job description

A leading biotech company is seeking a self-motivated GxP and Regulatory QA Lead to oversee compliance within clinical and non-clinical operations. The role requires at least 7 years of relevant experience in Quality Assurance within the pharmaceutical or biotechnology industry, alongside skills in Veeva platform management. Candidates should possess strong analytical abilities and a keen attention to detail. This full-time position supports innovative drug development processes and offers the opportunity to contribute to life-changing treatments.