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.
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