Clinical Quality and Compliance Lead

Overview

In this role, you will enable Ipsen’s clinical trials to run with the highest quality and regulatory compliance. You will partner with Site Management, Monitoring and TA leads to implement cluster quality plans and ensure adherence to SOPs, regulations, and QA standards. You will lead QA activities, CAPA management, and inspections readiness, driving continuous improvement across the Clinical Development Operations function. This is a hands-on, cross-functional leadership role shaping quality processes and assuring patient safety at scale.

Responsibilities

• Contribute to a long-term cluster quality plan aligning with Global Quality priorities
• Identify and remediate compliance risks at study and site level; measure effectiveness of remediation
• Supervise progress of remediation plans and perform QC checks on trials and processes
• Support Quality issues within Clinical Operations and capture them in Quality/Risk Management systems
• Coordinate CAPA ownership, root cause analysis, and RCA investigations with relevant owners and teams
• Assist Investigation Owner and CAPA Manager in applying structured problem-solving methodologies
• Advise on logistical aspects of issue resolution and engage stakeholders for RCA investigations
• Maintain CAPA milestones with CAPA Manager and escalate systemic issues to leaders
• Monitor audit and inspection announcements and ensure readiness with SMEs
• Provide support during internal audits/inspections and assist with CAPA activities after audits
• Collaborate with Global QA to align cluster plans with global quality and risk assessments
• Support procedural document review/creation and updates related to CAPA commitments
• Demonstrate local regulatory intelligence, impact assessments, and supplier due diligence with business quality
• Participate in special initiatives related to quality and compliance as required
• May assume additional responsibilities such as Quality/Compliance Champion or Business Process Owner
• Maintain fluent English and adapt to supported countries/cluster requirements

Key requirements

• Minimum 8 years in pharmaceutical industry with at least 5 years in GXP within clinical R&D or QA
• Experience in Quality Control/Quality Assurance, CAPA, and RCA
• Knowledge of the drug development process and SOP-driven clinical activities
• Experience with audits of sites, systems, vendors, and regulatory submissions an asset
• Strong planning, organization, multitasking, and time management
• Effective communication and stakeholder influence, with conflict resolution and negotiation skills
• Ability to plan, coordinate, and execute tasks independently
• Experience engaging with authorities and sites and driving continuous improvement
• Experience across Clinical Trial Phases 1-4 and Oncology is preferred

• strong communicator
• leadership and teamwork
• problem-solving and quick learner
• Quality Assurance (QA)
• GXP compliance
• CAPA management

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