Director, Vendor Management – Inspection Readiness

5 hours ago

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $178k - $221.6k / year

⏰ Full Time

🔴 Lead

🛒 Procurement

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Veracyte, Inc.

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Biotechnology • Healthcare Insurance • Pharmaceuticals

Veracyte, Inc. is a genomic diagnostics company focused on empowering clinicians with high-value molecular tests for diagnosing and treating cancer. The company provides a portfolio of genomic classifiers for various types of cancer, including thyroid, prostate, lung, breast, and bladder cancer, as well as interstitial lung disease. Veracyte's tests help clinicians and patients make informed decisions about cancer care by providing clear diagnostic and prognostic insights. The company's approach involves identifying unmet clinical needs and developing high-performance tests that are widely accessible globally through a CLIA and in vitro diagnostic-based model. Committed to elevating the standard of cancer care, Veracyte continues to expand its test portfolio and make significant contributions to the field of oncology diagnostics.

501 - 1000 employees

Founded 2013

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 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.

🎯 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