Head of Quality Audits & Regulatory Readiness

Personalis, Inc.; 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

Wellness benefits

Onsite gym

Job summary

Personalis, Inc., located in Fremont, California, seeks a Senior Manager / Associate Director for Quality Systems & Audits. This leadership role involves strategic oversight of the Internal Audit program and management of external audits. The ideal candidate will bring strong leadership skills and extensive regulatory experience.

This position offers a competitive salary range of $165,000 to $210,000 per year plus benefits.

Qualifications

• 8-10 years of experience in a Quality Assurance role within a regulated environment.
• Experience managing Quality Management Systems (QMS).
• Knowledge of ISO 13485, 21 CFR 820, GCP, and CLIA regulations.

Responsibilities

• Oversee the strategic vision for the Internal Audit program.
• Lead external regulatory inspections and documentation preparation.
• Provide mentorship to internal staff in audit capabilities.

Skills

Leadership skills

Regulatory expertise

Communication skills

Data compilation

Education

Bachelor’s degree in a scientific or related discipline

Advanced degree or professional audit certifications

Tools

Electronic document management systems (EDMS)

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Personalis, Inc., located in Fremont, California, seeks a Senior Manager / Associate Director for Quality Systems & Audits. This leadership role involves strategic oversight of the Internal Audit program and management of external audits. The ideal candidate will bring strong leadership skills and extensive regulatory experience.

This position offers a competitive salary range of $165,000 to $210,000 per year plus benefits.