Root Cause Investigation & CAPA Lead

CY Partners; Uxbridge; Hybrid; GBP 70,000 - 110,000; Full time

Job summary

CY Partners are recruiting an experienced Root Cause Investigation (RCI) & CAPA Lead for a leading life sciences organisation. The role centres on owning complex investigations, driving corrective and preventive actions, and strengthening quality processes in a regulated environment.

You will work with Quality, Safety, Clinical and Regulatory teams to reduce risk, prevent recurrence and enable a proactive, data-led approach to issue management, with a hybrid London pattern requiring two on-site

Qualifications

• Essential: GCP experience, PV or regulatory exposure.
• Experience in investigations and CAPA management within regulated environments.
• Strong knowledge of Quality Management Systems and regulatory requirements.
• Excellent stakeholder management and cross-functional leadership.

Responsibilities

• Lead end-to-end root cause investigations into complex, high-risk issues.
• Oversee CAPA development, implementation, closure and effectiveness reviews.
• Coach teams on investigation methodologies, risk assessments and SMART CAPA development.
• Collaborate with Quality, Safety, Clinical and Regulatory teams to strengthen processes.
• Assess issue criticality and support escalation.
• Monitor quality signals and drive management reviews.
• Drive continuous improvement across quality and issue management processes.

Skills

GCP experience

CAPA management

Quality Management Systems

Stakeholder management

Cross-functional collaboration

INVESTIGATION methodologies

Education

Degree in Life Sciences/Engineering

Job description

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.