Associate Director, Risk Management

Key Accountabilities / Core Job Responsibilities:

• Lead the GCP deviation and CAPA processes, ensuring timely investigation, implementation, effectiveness verification, and closure.
• Partner with study teams to identify, assess, and mitigate quality risks across clinical development programs using Quality by Design (QbD) and risk-based quality management principles.
• Serve as the subject matter expert on GCP quality risk management, guiding detection, investigation, documentation, and resolution of GCP noncompliance.
• Maintain quality oversight of the Clinical Trial Risk Tracking Program, ensuring risks are documented, monitored, and escalated.
• Analyze quality and compliance data, identify trends, develop meaningful metrics, and communicate insights to leadership and cross-functional stakeholders.
• Review deviations, noncompliance, and quality events to identify systemic risks and drive continuous improvement.
• Lead GCP and GVP vendor qualification and ongoing quality oversight to ensure regulatory and company compliance.
• Support regulatory inspections and audits with inspection readiness, documentation review, response development, and follow-up.
• Enhance the Quality Management System (QMS) by improving quality risk management processes, tools, and best practices.

Qualifications / Skills:

• Bachelor’s with 12+ years GCP Quality Assurance experience; or Master’s with 10+ years; or PhD with 7+ years; or equivalent education/experience.
• Expertise in ICH E6 GCP, GVP, FDA regulations, and applicable global requirements.
• Experience with QbD, RBQM, and QMS principles in clinical development.
• Experience leading GCP deviation, CAPA, vendor qualification, and quality risk management in a GxP environment.
• Strong analytical/critical thinking skills for risk evaluation and trend identification.
• Excellent written, verbal, and interpersonal communication; ability to influence cross-functionally without direct authority.
• Ability to manage multiple priorities in a fast-paced environment with high quality and attention to detail.

Benefits:

• Competitive total rewards package including 401k, healthcare coverage, and ESPP.