Veracyte, Inc.
High-value insights, high-impact decisions
Director, Vendor Management – Inspection Readiness
Location
California
Posted
100 days ago
Salary
$178K - $221.6K / year
Seniority
Lead
Bachelor Degree10 yrs expEnglishGoogle Cloud Platform
Job Description
• 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 applicable 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.
Job Requirements
- 10+ years of vendor management and inspection readiness experience in regulated industries
- 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
- Solid understanding of GAMP5 risk based computerized systems validation methodology
- Solid understanding of regulatory requirements, including GxP, GLP, GCP, CLIA, and data integrity frameworks.
Benefits
- Competitive compensation and benefits
- Professional development opportunities
- Flexible work arrangements
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