Associate Director, Audit Strategy & Vendor Quality - Princeton, NJ

Company: Msccn
Location: Princeton
Posted on: April 1, 2026

Job Description:

Job Description ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. 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-functional stakeholders, understanding priorities and providing independent quality guidance Provide independent quality guidance and present compliance, conformance, issues, and risks to support informed decision-making Deliver GxP guidance and training to business partners to strengthen quality awareness and execution, as needed Quality Innovation & Organizational Impact Partner with RDQ Digital and cross-functional teams to execute and implement transformation initiatives that drive automation, data-driven insights, and efficiency in vendor quality oversight processes Apply analytics and data science approaches to enhance risk identification, monitoring, and decision-making within vendor oversight Monitor external trends, evolving regulations, and industry best practices in vendor quality and oversight, and translate relevant insights into practical improvements to existing processes Additional Qualifications/Responsibilities Education B.S. or M.S. in a scientific, health, or quality-related discipline (or equivalent experience) Experience 8 years in Quality Assurance or regulated clinical development environments with strong GCP knowledge Hands-on experience executing risk-based audits, vendor oversight, and TPRM activities Experience supporting regulatory inspections and submission readiness Experience managing quality issues, CAPAs, and vendor performance follow-up Expertise & Skills Strong working knowledge of ICH/GCP and clinical research processes Applied understanding of quality risk management and trend analysis Clear written and verbal communication skills Strong project management and collaboration skills in a global environment Innovative mindset with interest in improving audit execution, vendor oversight, or quality processes. Exposure to data analytics or data science tools supporting quality risk identification and trend analysis. Travel Up to 20% LI-HYBRID If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Princeton - NJ - US: $163,210 - $197,770

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