Sr. Manager / Associate Director, Quality Audits

Audit Program Leadership & Governance

Audit Program Leadership & Governance

• Strategic Oversight: 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.
• Audit Lifecycle Management: 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.
• Executive Reporting: 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.
• Regulatory & Licensure Support: Lead external regulatory inspections and support the preparation and submission of crucial documentation for licensure and accreditation.

Cross-Functional Collaboration & CAPA Management

Cross-Functional Collaboration & CAPA Management

• Stakeholder Engagement: Actively partner with department heads and process owners to communicate audit results, evaluate systemic findings, and collaboratively resolve complex, audit-related compliance issues.
• Root Cause & Investigation Leadership: 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.
• Continuous Improvement: Champion continuous improvement initiatives across all Quality Systems, leveraging audit insights to drive operational excellence and robust process controls.

Team Mentorship & Professional Development

Team Mentorship & Professional Development

• Staff Coaching: Provide strategic direction, advanced training, and mentorship to internal staff to elevate the organization's audit capabilities and regulatory posture.
• Resource Coordination: Supervise the coordination of process owners and supporting documentation to ensure absolute preparedness for all internal and external evaluation windows.

Education and Experience

Education and Experience

• Education: Bachelor’s degree in a scientific, engineering, or related discipline. Advanced degree or professional audit certifications (e.g., ASQ CQA, Lead Auditor certification) highly preferred.
• Experience: 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).
• Regulatory Expertise: Deep, expert-level knowledge of ISO 13485, 21 CFR 820, ICH E6 (R3) Guidance for GCP , GCLP, CLIA, and CAP regulations.
• Methodological Mastery: Proven expertise in quality system methodologies, including CAPA management, Lean principles, 5 Whys, and Pareto Analysis.
• Technical Skills: 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).
• Leadership & Communication: Exceptional written, verbal, and interpersonal communication skills, with a proven track record of leading high-energy, demanding cross-functional initiatives with minimal supervision.

Pay

Pay

• Hiring Range: $165,000 to $210,000 per year

Schedule

Schedule

• Onsite: Monday, Tuesday, and an additional day