Director, Audit Strategy & Vendor Quality - Princeton, ...

, 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 Director, GCP Audit Strategy and Vendor Quality is accountable for designing and executing a global, risk-based audit strategy to ensure compliance with Good Clinical Practice (GCP) requirements. This role will drive robust vendor quality oversight across all clinical trial service providers in close partnership with Development Quality. Key responsibilities include leading strategic planning for audits, managing vendor-related quality investigations, CAPA development, and ensuring timely resolution of quality issues. The Director will establish and maintain a comprehensive vendor quality management framework for CROs and other external partners. This includes oversight of vendor quality programs and collaboration with cross-functional teams within RDQ, Outsourcing Management, and Procurement to embed proactive and predictive quality principles into vendor oversight. Core elements of this framework may encompass quality agreements, vendor quality oversight plans, governance structures, and continuous improvement initiatives to strengthen compliance and quality culture across the vendor network. , R,D Quality, Audit Strategy Design and implement a global, risk-based GCP audit strategy (programs, process, investigator sites, Service Providers aligned with ICH E6(R3), regulatory expectations, and company objectives. Lead and engage with business stakeholders to develop an integrated Global Audit Plan. Establish and evolve the Vendor Quality and TPRM strategy, ensuring consistent risk classification, due diligence, onboarding, oversight, and exit across the third-party lifecycle Monitor audit, inspection trends/metrics and identify process, program, and vendor risks, and develop predictive analytics to proactively identify emerging risks and drive continuous improvement leveraging external intelligence Champion and embed Quality by Design principles across Clinical third-party engagements, Vendor Quality Oversight, Due Diligence ,TPRM Provide strategic leadership for vendor quality oversight, ensuring independence, objectivity, and alignment with regulatory expectations Establish and maintain a comprehensive vendor quality oversight framework for GCP service providers Partner with Procurement, Outsourcing Management, Clinical Operations and Development Quality to ensure vendor qualification, performance monitoring, and issue resolution. Support and drive governance forums (where applicable) with key vendors to ensure compliance and quality culture and regulatory expectation Lead and oversee vendor due diligence activities, including risk assessments, audits, and quality evaluations for M,A, in-licensing, outsourcing, and strategic partnerships Define expectations and governance for Third-Party Risk Management (TPRM), including risk stratification, audit frequency, issue escalation, and performance monitoring Partner with Development Quality and applicable business functions to assure vendor quality risks are proactively identified, trended, and addressed throughout the vendor lifecycle Leads the development of Clinical Quality Agreements and the set-up of the respective quality governance, for preferred/critical service providers where applicable Define and drive KRIs/KQIs with key vendors and establish clear accountability, cadence, and measurable outcomes., , R,D Quality, Audit Strategy Design and implement a global, risk-based GCP audit strategy (programs, process, investigator sites, Service Providers aligned with ICH E6(R3), regulatory expectations, and company objectives. Lead and engage with business stakeholders to develop an integrated Global Audit Plan. Establish and evolve the Vendor Quality and TPRM strategy, ensuring consistent risk classification, due diligence, onboarding, oversight, and exit across the third-party lifecycle Monitor audit, inspection trends/metrics and identify process, program, and vendor risks, and develop predictive analytics to proactively identify emerging risks and drive continuous improvement leveraging external intelligence Champion and embed Quality by Design principles across Clinical third-party engagements, Vendor Quality Oversight, Due Diligence ,TPRM Provide strategic leadership for vendor quality oversight, ensuring independence, objectivity, and alignment with regulatory expectations Establish and maintain a comprehensive vendor quality oversight framework for GCP service providers Partner with Procurement, Outsourcing Management, Clinical Operations and Development Quality to ensure vendor qualification, performance monitoring, and issue resolution. Support and drive governance forums (where applicable) with key vendors to ensure compliance and quality culture and regulatory expectation Lead and oversee vendor due diligence activities, including risk assessments, audits, and quality evaluations for M,A, in-licensing, outsourcing, and strategic partnerships Define expectations and governance for Third-Party Risk Management (TPRM), including risk stratification, audit frequency, issue escalation, and performance monitoring Partner with Development Quality and applicable business functions to assure vendor quality risks are proactively identified, trended, and addressed throughout the vendor lifecycle Leads the development of Clinical Quality Agreements and the set-up of the respective quality governance, for preferred/critical service providers where applicable Define and drive KRIs/KQIs with key vendors and establish clear accountability, cadence, and measurable outcomes., Investigations, Escalations ,Critical Issues Lead and/or support for-cause, critical, and complex investigations, involving internal processes and/or vendors, ensuring robust root cause analysis and sustainable remediation, as needed, Regulatory, Health Authority Inspection Readiness Ensure inspection readiness in partnership with Development Quality, and Outsourcing Management , clearly demonstrating effective vendor oversight and TPRM controls Partner with Development Quality Asset Leads to ensure vendor inspection readiness across programs Provide strategic guidance during regulatory inspections and lead remediation planning for audit findings, , , , ,

Created: 2026-03-13