Associate Director, Audit Strategy and Vendor Quality

Associate Director, Audit Strategy and Vendor Quality (R1600063)

Location
:
Princeton, NJ, US.
Compensation
: $163,210 - $197,770 per year plus incentives.
Travel
:
Up to 20%.

• Operationalize and execute risk-based audit and quality strategy across Therapeutic Areas, R&D processes, investigator sites, vendors, and digital health aligned with ICH E6(R3) and regulatory expectations.
• Plan, conduct, and report audits and assessments; ensure consistency, quality, and timely delivery with the Clinical Auditing team and stakeholders.
• Identify, assess, and report quality risks; contribute to trend analysis, metrics, and evidence-based insights.
• Translate audit and inspection findings into corrective and preventive actions; monitor audit trends and emerging risks.
• Implement Quality by Design principles within assigned programs and processes.
• Conduct vendor due diligence, onboarding assessments, and ongoing quality oversight; monitor vendor performance and quality events.
• Execute vendor quality oversight framework for CROs and service providers; implement Third-Party Risk Management controls.
• Escalate vendor quality risks to leadership and governance forums.
• Support the development of Clinical Quality Agreements and participate in quality governance.
• Support quality issues, deviations, investigations, root cause analysis, and remediation planning.
• Escalate critical or systemic risks to senior leadership with clear data and recommendations.
• Support inspection readiness activities; prepare documentation, metrics, and narratives.
• Participate in Health Authority inspections; contribute to responses and follow-up actions.
• Provide quality input to product submissions.
• Support M&A due diligence on GxP readiness and quality risks; provide independent quality guidance.
• Build relationships with cross-functional stakeholders and provide independent guidance.
• Deliver GxP guidance and training to business partners.
• Partner with RDQ Digital and other teams to implement transformation initiatives for vendor quality oversight.
• Apply analytics and data science to enhance risk identification, monitoring, and decision-making.
• Monitor external trends, regulations, and industry best practices; translate insights into process improvements.

• B.S. or M.S. in a scientific, health, or quality-related discipline (or equivalent experience).
• 8+ years in Quality Assurance or regulated clinical development environments; 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.

• Strong knowledge of ICH/GCP and clinical research processes.
• Applied understanding of quality risk management and trend analysis.
• Clear written and verbal communication.
• Strong project management and collaboration in a global environment.
• Innovative mindset focused on improving audit execution, vendor oversight, or quality processes.
• Exposure to data analytics or data science tools for risk identification and trend analysis.

• Health coverage: medical, pharmacy, dental, vision.
• Wellbeing support programs and employee assistance.
• 401(k) plan and pension options; disability, life, and supplemental insurance.
• Paid time off:
  Unlimited paid sick time, up to 2 volunteer days per year, and other leave options. Flexible vacation for exempt employees.
• Global shutdown schedule during holiday season.

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