Root Cause Investigation & CAPA Lead
Location: London (Hybrid – 2 days on-site per week)
CY Partners are partnering with a leading organisation within the pharmaceutical and life sciences sector to recruit an experienced Root Cause Investigation (RCI) & CAPA Lead.
This is an exciting opportunity for a quality professional to take ownership of complex investigations, drive effective corrective and preventive actions, and influence continuous improvement across a regulated environment.
Working closely with Quality, Safety, Clinical and Regulatory teams, you will play a key role in strengthening quality processes, reducing risk and preventing recurrence, whilst supporting a proactive, data-led approach to issue management.
Key Responsibilities
- Lead end-to-end root cause investigations into complex and high-risk issues, delivering evidence-based outcomes.
- Oversee CAPA development, implementation, closure and effectiveness reviews.
- Coach colleagues on investigation methodologies, risk assessments and SMART CAPA development.
- Work with cross-functional stakeholders to improve processes and prevent recurrence.
- Assess issue criticality and support appropriate escalation.
- Monitor quality signals and business performance, facilitating management reviews.
- Drive continuous improvement across quality and issue management processes.
About You
- Degree in Life Sciences, Engineering, Quality or a related discipline, or equivalent experience.
- Significant experience in investigations, CAPA management, quality or risk within pharmaceutical, vaccines or life sciences environments.
- Essential: GCP experience, either alongside Pharmacovigilance (PV) experience or as your primary area of expertise.
- Experience working within regulated environments, with knowledge of GCP and ideally GVP and/or GLP.
- Proven experience leading root cause investigations and implementing effective CAPAs.
- Strong understanding of Quality Management Systems and regulatory requirements.
- Excellent stakeholder management and influencing skills, with experience leading cross-functional teams.
- Comfortable working hybrid, with 2 days per week on-site in London.
Desirable Experience
- Training or certification in Root Cause Analysis, Six Sigma or Lean.
- Experience supporting regulatory inspections and audits.
- Experience assessing issue criticality and Serious Breaches.
- Demonstrable success in process improvement and CAPA effectiveness.
- Experience with digital quality management systems and analytics tools.
- Knowledge of global regulatory frameworks relevant to clinical and quality activities.
This is a fantastic opportunity to make a tangible impact within a leading life sciences environment, influence quality strategy and drive meaningful improvements.
We look forward to receiving your application.