Associate Director, Vendor Quality Management (Hybrid)

Role Summary

The Associate Director, Vendor Quality Management is responsible for proactively and comprehensively monitoring vendor quality and compliance risk for vendors participating in GxP regulated environments across product modalities. This role develops, maintains, and disseminates vendor data and analytics, including vendor key performance indicators, vendor quality metrics, and a vendor risk scorecard, to QA and to key business partners at the enterprise and program levels. It drives continuous improvement in Vertex vendor quality processes and governance to ensure regulatory adherence and supports QA oversight and management of complex vendor issues.

Responsibilities

• Maintains and manages an innovative, risk-based model for quality oversight and management of GxP vendors across product modalities.
• Maintains up-to-date integrated quality and risk scorecards across GxP vendors.
• Partners with Quality and business stakeholders to ensure adequate quality processes, governance and quality oversight across GxP vendors.
• Serves as a consultant to Vertex QA teams and business functions in identifying risk management strategies, selecting vendors and remediating complex vendor issues.
• Maintains and evolves vendor quality-related processes, procedures, and templates in collaboration with Quality and business stakeholders.
• Monitors vendor metrics and dashboards for emerging trends across vendors and communicates insights to QA and business stakeholders.
• Drives awareness and application of evolving regulatory requirements and expectations for vendor management across GxPs and product modalities.
• Partners with QA operational, audit, and inspection teams to share and align on risks, manage complex quality issues, implement process improvements, and drive quality outcomes, including inspection readiness.
• Serves as a subject-matter expert and participates in inspection preparation and management activities relevant to vendor processes, risk management and oversight.
• Identifies quality improvements to Vertex quality systems to maintain compliance and improve efficiency using risk-based methodologies related to vendor management/vendor oversight.

Skills

• Demonstrated working knowledge of US and international regulatory requirements and guidance applicable to drug, biologic, combination product, and/or device R&D, manufacturing, and distribution.
• In-depth knowledge of vendor selection and oversight requirements in one or more GxP areas.
• Strong risk and issue management capabilities with a track record applying them to third-party suppliers in GxP contexts.
• Strong oral and written communication and interpersonal skills to convey complex concepts and persuade others.
• Strategic thinking with the ability to collaborate and execute at a tactical level.
• Strong analytical skills to translate data into risk-informed insights for decision-making.
• Experience advising, coaching, or mentoring junior staff.

Education

• Bachelor's degree in a scientific or allied health field (or equivalent degree)
• Typically 8 years of relevant work experience, or the equivalent combination of education and experience.