Senior Quality & Audit Leader – Global Compliance & CAPA

Personalis; Fremont (CA); On-site; USD 165,000 - 210,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

401(k) match

Tuition reimbursement

Onsite gym

Commuter benefits

Job summary

Personalis, based in Fremont, California, is looking for a Senior Manager / Associate Director, Quality Systems & Audits to lead the strategic oversight of their global Internal Audit program. This high-level position requires extensive experience in Quality Management Systems within FDA-regulated environments.

The ideal candidate will have strong leadership skills and a deep understanding of regulatory compliance, driving continuous improvement across all quality systems. This role involves oversight of both internal and external audits, ensuring adherence to regulatory requirements.

Qualifications

• 8-10 years of progressive experience in Quality Assurance in FDA-regulated environments.
• Expert-level knowledge of ISO 13485, 21 CFR 820, and CLIA regulations.
• Proven expertise in quality system methodologies including CAPA management.

Responsibilities

• Oversee the strategic vision for the corporate Internal Audit program.
• Manage the end-to-end audit lifecycle and resource planning.
• Lead external regulatory inspections and documentation preparations.

Skills

Leadership skills

Quality Management Systems (QMS)

Regulatory compliance

Root Cause Analysis

Communication skills

Education

Bachelor's degree in a scientific, engineering, or related discipline

Advanced degree or professional audit certifications

Tools

Electronic Document Management Systems (EDMS)

Excel

Microsoft Office Suite

Job description

Personalis, based in Fremont, California, is looking for a Senior Manager / Associate Director, Quality Systems & Audits to lead the strategic oversight of their global Internal Audit program. This high-level position requires extensive experience in Quality Management Systems within FDA-regulated environments.

The ideal candidate will have strong leadership skills and a deep understanding of regulatory compliance, driving continuous improvement across all quality systems. This role involves oversight of both internal and external audits, ensuring adherence to regulatory requirements.