GCP / GVP Quality & CAPA Lead

CY Partners; Uxbridge; Hybrid; GBP 85,000 - 120,000; Full time

Job summary

CY Partners are partnering with a leading organisation in the pharmaceutical and life sciences sector to recruit an experienced GCP/GVP Quality & CAPA Lead. You will lead complex investigations, oversee CAPA development and drive improvements across a regulated environment.

Working closely with Clinical, Pharmacovigilance, Quality and Regulatory teams, you will strengthen compliance, identify risks and ensure effective actions are implemented to prevent recurrence.

Qualifications

• Degree in Life Sciences, Pharmacy or related discipline.
• Significant experience within GCP, GVP, Clinical Quality Assurance or Pharmacovigilance Quality.
• Strong understanding of GCP and/or GVP regulatory requirements.
• Proven experience leading investigations, managing quality events and implementing effective CAPAs.
• Excellent stakeholder management and communication skills.
• Comfortable working hybrid, with 2 days per week on-site in London.

Responsibilities

• Lead root cause investigations into complex and high-risk quality and compliance issues.
• Oversee CAPA development, implementation, closure and effectiveness reviews.
• Investigate GCP and GVP-related compliance issues, identifying trends and improvement opportunities.
• Coach colleagues on investigation methodologies, risk assessments and CAPA development.
• Work cross-functionally with Clinical, Pharmacovigilance, Quality and Regulatory teams.
• Assess issue criticality and support escalation, including Serious Breaches where appropriate.
• Monitor quality trends and support management reviews.
• Drive continuous improvement across quality and compliance processes.

Skills

GCP/GVP knowledge

CAPA leadership

Investigations

Regulatory compliance

Stakeholder management

Communication skills

Education

Degree in Life Sciences or Pharmacy

Job description

GCP / GVP Quality & CAPA Lead

CY Partners are partnering with a leading organisation within the pharmaceutical and life sciences sector to recruit an experienced GCP / GVP Quality & CAPA Lead.

This is an excellent opportunity for a quality professional with experience in GCP, GVP, Clinical Quality or Pharmacovigilance Compliance to lead complex investigations, oversee corrective and preventive actions (CAPAs) and drive continuous improvement across a regulated environment.

Working closely with Clinical, Pharmacovigilance, Quality, Safety and Regulatory teams, you will play a key role in strengthening compliance, identifying risks and ensuring effective actions are implemented to prevent recurrence.

Key Responsibilities

• Lead root cause investigations into complex and high-risk quality and compliance issues.
• Oversee CAPA development, implementation, closure and effectiveness reviews.
• Investigate GCP and GVP-related compliance issues, identifying trends and improvement opportunities.
• Coach colleagues on investigation methodologies, risk assessments and CAPA development.
• Work cross-functionally with Clinical, Pharmacovigilance, Quality and Regulatory teams.
• Assess issue criticality and support escalation, including Serious Breaches where appropriate.
• Monitor quality trends and support management reviews.
• Drive continuous improvement across quality and compliance processes.

About You

• Degree in Life Sciences, Pharmacy or a related discipline, or equivalent experience.
• Significant experience within GCP, GVP, Clinical Quality Assurance or Pharmacovigilance Quality.
• Strong understanding of GCP and/or GVP regulatory requirements.
• Proven experience leading investigations, managing quality events and implementing effective CAPAs.
• Good understanding of Quality Management Systems and regulatory compliance.
• Excellent stakeholder management and communication skills.
• Comfortable working hybrid, with 2 days per week on-site in London.

Desirable Experience

• Experience across both GCP and GVP environments.
• Experience managing Serious Breaches and significant compliance issues.
• Training in Root Cause Analysis, Six Sigma or Lean methodologies.
• Experience supporting regulatory inspections and audits.
• Knowledge of global clinical and pharmacovigilance regulatory frameworks.
• Experience with digital Quality Management Systems and analytics tools.

The Opportunity

This is a fantastic opportunity for a GCP or GVP quality professional to take on a broader leadership role, influence quality processes and drive meaningful improvements across a leading life sciences organisation.