Sr Director GCP Quality Assurance - relocation to Bay Area

THIS REQUIRES TO LOCATED IN SAN FRANCISO - WILL RECEIVE RELOCATION PACKAGEPosition: Clinical Quality Assurance Sr. Director.Location: San FranciscoReporting To: SVP of QualityA 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.