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.
If you have a background in GCP, GVP, Clinical Quality or Pharmacovigilance Quality and experience in investigations and CAPA management, we would love to hear from you.
We look forward to receiving your application.