Sr. Manager / Associate Director, Quality Audits

Personalis, Inc•Fremont, CA

1d•$165,000 - $210,000•Onsite

About The Position

Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to Veterans Affairs' Million Veteran Program. To enable cancer and population sequencing, Personalis' Clinical Laboratory was built with a focus on clinical accuracy, quality, big data, scale and efficiency. The laboratory is GxP-aligned as well as Clinical Laboratory Improvement Amendments of 1988-certified and College of American Pathologists-accredited. Personalis is based in Fremont, California. Summary: The Senior Manager / Associate Director, Quality Systems & Audits is a high-level leadership role within the Quality Assurance department. Reporting directly to the Director of Quality Assurance, this individual is responsible for the strategic oversight, design, and execution of the global Internal Audit program, as well as leading the readiness and management of all External Audits (including regulatory inspections and accreditation assessments). The successful candidate will have strong leadership skills and possess extensive experience managing Quality Management Systems (QMS) within highly regulated environments, driving compliance, governance, and continuous improvement across the organization with a high degree of autonomy.

Requirements

Bachelor’s degree in a scientific, engineering, or related discipline.
A minimum of 8–10 years of progressive experience in a Quality Assurance role within an FDA-regulated or ISO-certified medical device, IVD, or clinical laboratory environment (with at least 5 years operating at a senior specialist, project management, or leadership level).
Deep, expert-level knowledge of ISO 13485, 21 CFR 820, ICH E6 (R3) Guidance for GCP , GCLP, CLIA, and CAP regulations.
Proven expertise in quality system methodologies, including CAPA management, Lean principles, 5 Whys, and Pareto Analysis.
Advanced proficiency in data compilation, metric synthesis, corporate SOP authorship, and the use of electronic document management systems (EDMS) alongside standard office suites (Word, Excel, PowerPoint).
Exceptional written, verbal, and interpersonal communication skills, with a proven track record of leading high-energy, demanding cross-functional initiatives with minimal supervision.

Nice To Haves

Advanced degree or professional audit certifications (e.g., ASQ CQA, Lead Auditor certification) highly preferred.

Responsibilities

Establish, maintain, and oversee the strategic vision for the corporate Internal Audit program and external audit readiness frameworks to ensure compliance with CLIA, CAP, ISO 13485, 21 CFR 820, IVDR, and GCP and GCLP.
Oversee and execute the end-to-end audit lifecycle, including the definition of corporate audit programs, master scheduling, resource planning, and formal scoping of complex quality system projects.
Author, review, and finalize high-level audit reports and compliance metrics. Present comprehensive monthly trend reports, performance metrics, and status updates directly to executive leadership for Management Review.
Lead external regulatory inspections and support the preparation and submission of crucial documentation for licensure and accreditation.
Actively partner with department heads and process owners to communicate audit results, evaluate systemic findings, and collaboratively resolve complex, audit-related compliance issues.
Provide expert guidance and lead cross-functional investigation teams in executing comprehensive root cause analyses for CAPAs, deviations, and non-conformances stemming from internal and external audits.
Champion continuous improvement initiatives across all Quality Systems, leveraging audit insights to drive operational excellence and robust process controls.
Provide strategic direction, advanced training, and mentorship to internal staff to elevate the organization's audit capabilities and regulatory posture.
Supervise the coordination of process owners and supporting documentation to ensure absolute preparedness for all internal and external evaluation windows.