Sr Director GCP Quality Assurance - relocation to Bay Area

THIS REQUIRES TO LOCATED IN SAN FRANCISO - WILL RECEIVE RELOCATION PACKAGE

Position: Clinical Quality Assurance Sr. Director.

Location: San Francisco

Reporting To: SVP of Quality

A precision medicines company focused on transforming outcomes for patients with autoimmune diseases through innovative treatments.

Role Overview:

The Sr. Director will oversee GCP/GVP compliance across ongoing clinical studies, collaborating with multiple teams to ensure quality is integrated throughout the clinical program lifecycle.

Key Responsibilities:

• Develop and maintain GCP QA programs and policies.
• Ensure compliance with health authority regulations.
• Act as the GCP QA expert and primary contact for related issues.
• Establish audit plans and perform audits; lead external quality auditors.
• Represent Quality in project teams and inspections.
• Manage Quality Review Board content and prepare KPIs and metrics.
• Review key clinical documents for compliance and data integrity.
• Lead inspection readiness activities and liaise with health authorities and partners.
• Support provider selection and develop compliance reports.

Qualifications:

• Bachelor’s or advanced degree in Biology, Chemistry, or related field.
• Minimum 12 years of GCP/GVP QA experience.
• Strong knowledge of FDA and global health authority regulations.
• Experience with small molecule products and solid oral dosage forms.

Skills:

• Strong communication and analytical skills.
• Ability to make sound decisions amid complexity.
• Experience in quality management systems.
• Proven leadership and collaborative abilities.
• Some travel required.