Sr. Manager / Associate Director, Quality Audits

TL;DR

Sr. Manager / Associate Director, Quality Audits: Strategic oversight and execution of the global Internal Audit program and external audit readiness, with an accent on compliance governance across highly regulated quality systems. Focus on leading audit lifecycle management, executive reporting, and CAPA/root-cause investigations to drive continuous improvement and inspection readiness.

Location: Fremont, CA

Salary: $165,000–$210,000 per year

Company

hirify.global is a leader in advanced cancer genomics for precision cancer therapies and diagnostics.

What you will do

• Establish and oversee the strategic vision for the corporate Internal Audit program and external audit readiness frameworks.
• Manage the end-to-end audit lifecycle, including master scheduling, resource planning, and scoping of complex quality system projects.
• Author and finalize audit reports and compliance metrics; present monthly trend/performance updates for Management Review.
• Lead external regulatory inspections and support licensure and accreditation documentation submissions.
• Partner with department heads to resolve systemic audit findings and lead cross-functional root-cause analyses for CAPAs, deviations, and non-conformances.
• Coach staff and coordinate process owners and supporting documentation to ensure readiness for internal and external evaluation windows.

Requirements

• 8–10 years of progressive Quality Assurance experience in an FDA-regulated or ISO-certified medical device, IVD, or clinical laboratory environment, including at least 5 years at a senior specialist/project management/leadership level.
• Expert knowledge of ISO 13485, 21 CFR 820, ICH E6 (R3) for GCP, GCLP, CLIA, and CAP regulations.
• Proven quality system methodology expertise, including CAPA management, Lean principles, 5 Whys, and Pareto Analysis.
• Strong leadership and communication skills, with a track record of leading demanding cross-functional initiatives with minimal supervision.
• Advanced skills in metric synthesis, corporate SOP authorship, and use of electronic document management systems (EDMS) plus standard office tools.
• Onsite schedule: Monday, Tuesday, and an additional day.

Culture & Benefits

• Full-time regular position with an annual performance-based bonus (or sales incentive plan) and long-term incentive units (equity).
• Comprehensive medical, financial, and/or other benefits, including 401(k) match, ESPP, tuition reimbursement, sick/vacation time, and commuter benefits/EV charging.
• Onsite gym and wellness benefits.
• Equal opportunity employer committed to inclusion and reasonable accommodations.