Director, Vendor Management & Inspection Readiness

The Position:

We are seeking a highly experienced and collaborative Director of Vendor Management and Inspection Readiness to own the respective programs for all regulated applications at Veracyte that directly help our company expand and develop new diagnostic solutions to improve patient outcomes and lower healthcare costs.

Vendor Management is a key role in overseeing and managing relationships with third-party vendors in a regulated industry, ensuring that all vendor activities comply with applicable regulatory requirements, Veracyte policies, and quality agreements. This role involves managing vendor performance, risk assessments, and compliance monitoring to support operational efficiency and minimize risk.

Inspection Readiness ensures the Digital Transformation Team (DXT) maintains a continuous state of compliance and is fully prepared for regulatory inspections and audits. This role partners with DXT to develop inspection readiness strategies, via programs of self-inspection and internal audits.

Key Responsibilities

• Vendor Selection & Onboarding: Assist in the vendor selection process by conducting due diligence and risk assessments to ensure vendors meet regulatory, quality, and operational standards.
• Vendor Relationship Management: Serve as the primary point of contact for applicable vendors, maintaining business relationships. Conduct regular performance reviews with vendors, ensuring they meet Key Performance Indicators (KPIs) and Service Level Agreements (SLAs).
• Issue Resolution & Dispute Management: Manage and resolve any vendor-related issues or disputes promptly, including non-compliance, performance concerns, and quality discrepancies.
• Continuous Improvement & Process Optimization: Continuously assess and improve vendor management processes, identifying opportunities to streamline workflows, reduce costs, and improve vendor relations.
• Compliance & Risk Management: Ensure that all vendors comply with appliable regulatory requirements. Develop and maintain a system for ongoing vendor monitoring to identify and mitigate any compliance or operational risks. Implement a risk-based audit program.
• Inspection Readiness & Compliance: Develop and maintain an inspection readiness program that ensures DXT is inspection ready at all times. Conduct periodic internal audits, and gap assessments, to identify compliance risks. Lead remediation activities, track corrective and preventive actions (CAPAs), and verify implementation effectiveness.
• Documentation & Quality Systems: Ensure effective document control, including audit trail reviews, data integrity checks, and timely updates to controlled documents. Support the creation, revision, and harmonization of SOPs and quality processes.
• Regulatory Awareness: Stay current on applicable regulatory expectations, inspection trends, guidance documents, and industry best practices.

Who You Are:

Required:

• 10+ years of vendor management and inspection readiness experience in regulated industries, with increasing levels of responsibility.
• Bachelor's or Master's degree in Life Sciences, Bioinformatics, Computer Science, or a related field.
• Proven experience implementing and/or managing vendor relationships and driving performance improvements.
• Proven experience implementing and/or managing an inspection readiness program and driving remediation efforts.
• Strong communication and interpersonal skills, with the ability to lead cross-functional discussions.
• Solid understanding of GAMP5 risk based computerized systems validation methodology
• Solid understanding of regulatory requirements, including GxP, GLP, GCP, CLIA, and data integrity frameworks.

Preferred:

• Excellent communication, negotiation, and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Familiarity with vendor management software and tools.
• Attention to detail and the ability to work under pressure.

#LI-Onsite, #LI-Hybrid, or #LI-Remote

For candidates based in our San Diego office, the salary range is $186,900 - $211,000.

For candidates based in our South San Francisco office, the salary range is $196,200 - $221,600.

For candidates working remote (US), the salary range is $178,000 - $201,000.