Manager, Quality Clinical Risk Management

Overview

As Manager, you lead clinical quality-risk activities across trials and programs, translating risk signals into proactive mitigations and quality decisions. You work with cross-functional teams to ensure inspection readiness, CAPA implementation, and escalation processes. The role combines hands-on risk ownership with influence across R&D and external partners. You contribute to a program that advances innovative medicines with patient safety at the core. This opportunity offers impact through shaping risk management practices in a global context.

Responsibilities

• Identify and assess key risks in clinical protocols and setups; advise on mitigations
• Lead risk area reviews with Risk Owners; monitor progress and identify new risks
• Maintain Clinical Quality Plans risk monitoring in the quality risk repository
• Drive quality risk monitoring reviews; coach others on risk mitigation
• Communicate risk updates to R&D Business Partners via governance forums
• Provide guidance on significant quality issues (SQI) and escalation to senior management
• Support CAPA development and effectiveness checks in collaboration with partners
• Lead Cross-Functional Trial Team in QPR content development and follow-up
• Oversee inspection readiness activities; prepare narratives and sites for inspection
• Provide front/back room inspection support for Sponsors and third parties
• Offer independent consultancy on research quality and regulatory interpretation
• Coordinate quality integration for assets during post-L&A activities

Key requirements

• 8+ years in healthcare/pharma or related fields
• Proficiency in Microsoft Office
• Fluent in English (spoken and written)
• Strong GCP quality and/or clinical trials experience
• Cross-functional collaboration experience
• Adaptability to changing business needs
• Ability to operate across diverse regional/global structures
• Travel up to 10% (domestic and some international)

• excellent interpersonal and communication skills
• strong stakeholder management
• proactive problem-solving
• GMP/GLP/GPvP knowledge
• ICH guidelines familiarity
• data analytics and visualization (Tableau, Spotfire)

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