Associate Director, Audit Strategy and Vendor Quality

Working with Us
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The Associate Director, Audit Strategy and Vendor Quality supports the development and execution of risk-based audit strategies across Therapeutic Areas, R&D processes, and external vendors. This role focuses on operationalizing risk-based audit plans, delivering effective audit execution, supporting quality investigations and CAPA management, as well as proactively identifying and escalating quality risks. The Associate Director will lead and support maintaining and applying the vendor quality management framework such as vendor oversight plans, quality agreements, and governance metrics and supports inspection readiness and product submission activities through consistent, risk-based quality execution in partnership with RDQ Development Quality and business stakeholders.

R&D Quality, Audit Strategy

• Operationalize and execute the risk-based audit and quality strategy across Therapeutic Areas, R&D processes, investigator sites, vendors, and digital health aligned with ICH E6(R3), regulatory expectations, and company objectives
• Lead the planning, conduct, and reporting of audits and assessments, ensuring consistency, quality, and timely delivery, in partnership with Clinical Auditing team, Development Quality and business stakeholders
• Identify, assess, and escalate quality risks, contributing to trend analysis, metrics, and evidence-based insights
• Support continuous improvement initiatives by translating audit and inspection findings into actionable corrective and preventive actions, monitoring audit trends and identifying emerging risks
• Support implementation of Quality by Design principles within assigned programs and processes

Vendor Quality Oversight, Due Diligence & TPRM

• Conduct and support vendor due diligence, onboarding assessments, and ongoing quality oversight activities
• Monitor vendor performance, quality events, and compliance metrics; escalate risks and trends as appropriate
• Execute on the established comprehensive vendor quality oversight framework for CROs and other service providers
• Implement Third-Party Risk Management (TPRM) controls in alignment with established governance, including vendor risk classification, oversight planning, and documentation
• Escalate vendor quality risks identified throughout the lifecycle to leadership or in appropriate governing forums in partnership with Development Quality
• Support the development of Clinical Quality Agreements and participate in the respective quality governance, for service providers

Quality Issues & Investigations

• Support quality issues, deviations, and investigations, including contributing to root cause analysis and remediation planning, as needed
• Escalate critical or systemic risks to senior leadership with clear data and recommendations
• Contribute to trend analysis and risk reporting to support proactive quality management

Regulatory, Health Authority & Inspection Readiness

• Support inspection readiness activities, including preparation of documentation, metrics, and quality narratives, as needed, in partnership with RDQ Development Quality
• Participate in Health Authority inspections and contribute to responses and follow-up actions, as needed
• Provide quality input to product submission activities as required

Business Partnership, Enablement and M&A

• Support execution of M&A due diligence activities based on the established M&A framework for evaluating target company GxP readiness and risks from a quality perspective

• Build strong working relationships with cross-func