Associate Director, Vendor Quality Management (Hybrid)

Role Summary

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 KPIs, quality metrics, and a vendor risk scorecard, to QA and key business partners at enterprise and program levels. It drives continuous improvement in vendor quality processes and governance to ensure regulatory adherence and supports QA operational oversight and management of complex vendor issues.

Responsibilities

• Maintains and manages a 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 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 and communicates insights to QA and business stakeholders.
• Drives awareness and application of evolving regulatory requirements for vendor management across GxPs and product modalities.
• Partners with QA operations, audit, and inspection teams to share and align on risks, manage quality issues, implement process improvements, and drive quality outcomes including inspection readiness.
• Serves as an SME 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 related to vendor management/vendor oversight.

Knowledge And Skills

• Working knowledge of US and international regulatory requirements and standards applicable to drug, biologic, combination product, and/or device R&D, manufacturing, and distribution.
• Knowledge of regulatory requirements specific to vendor selection and oversight in one or more GxP areas.
• Strong risk management and issue management capabilities applied to third-party suppliers in GxP activities.
• Excellent verbal and written communication and interpersonal skills.
• Strategic thinking with the ability to collaborate and execute at a tactical level.
• Strong analytical abilities 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).
• Typically 8 years of relevant work experience, or equivalent combination of education and experience.