Compliance Manager

Role Summary
You will lead Root Cause Investigation (RCI) and Corrective and Preventive Action (CAPA) activities across Research & Development and related functions. You will collaborate with Quality, Safety, Clinical and Regulatory teams to resolve complex issues, reduce future risk, and drive continuous improvement through practical, data-driven solutions. This role offers significant visibility, career growth, and the opportunity to shape processes that help unite science, technology and talent to get ahead of disease together.

Key Responsibilities

• Lead end-to-end root cause investigations for cross-functional and high-risk issues using structured methodologies to arrive at evidence-based conclusions.
• Coach and support colleagues on investigation tools, risk assessments, and SMART CAPA design.
• Oversee CAPA implementation, closure, and effectiveness monitoring.
• Partner with process owners and stakeholders to simplify workflows, reduce recurrence, and improve issue management practices.
• Facilitate management reviews and governance oversight by proactively monitoring trends, signals, and business performance.
• Assess issues for criticality and recommend appropriate escalation and remediation actions.

Required Qualifications & Experience

• Degree in Life Sciences, Engineering, Quality, or a related discipline, or equivalent experience.
• Significant experience in issue investigation, CAPA management, quality, or risk management roles within pharmaceutical, vaccines, or life sciences environments.
• Experience working within GCP, GVP and/or GLP regulated environments.
• Demonstrated experience leading root cause analyses and implementing CAPAs in regulated settings.
• Strong knowledge of Quality Management Systems (QMS) and regulatory expectations.
• Proven ability to influence within a matrix organization and lead cross-functional teams.
• Comfortable working in a hybrid work model with regular on-site presence.

Preferred Qualifications & Skills

• Advanced degree (MSc, PhD, or equivalent) in a relevant discipline.
• Formal training or certification in Root Cause Analysis, Lean, Six Sigma, or similar methodologies.
• Experience supporting regulatory inspections and audit preparedness activities.
• Experience assessing issue criticality and Serious Breaches.
• Track record of process improvement with measurable CAPA effectiveness outcomes.
• Experience using digital tools for quality management, analytics, and workflow tracking.
• Familiarity with global regulatory frameworks relevant to clinical and quality activities.