Senior Clinical Quality & Compliance Lead

Ipsen Biopharm Ltd; Greater London; On-site; GBP 85,000 - 110,000; Full time

Job summary

Ipsen Biopharm Ltd in the UK is seeking a Clinical Quality and Compliance Lead to steer quality and regulatory compliance across Ipsen clinical trials. You will partner with Head Site Management and Monitoring and TA Leads to ensure adherence to Quality Standards and SOPs while sustaining inspection readiness.

The role demands independence, strong communication, and a proven ability to drive continuous improvement within Clinical Development Operations.

Qualifications

• Minimum 8 years pharmaceutical industry experience.
• At least 5 years GXP within clinical development or quality assurance.
• Experience in CAPA, RCA, audits of clinical investigative sites/vendors.
• Fluent in English.
• Strong communication and stakeholder management.

Responsibilities

• Develop long-term quality plans for clusters and monitor remediation actions.
• Support QA issues via CAPA owner and RCA processes.
• Act as liaison between record owners and quality leaders.
• Lead CAPA milestones with CAPA Manager.
• Ensure inspection readiness for audits and inspections.
• Collaborate with Global QA and TA heads on documentation requests.

Skills

GXP compliance

CAPA process

Root Cause Analysis

Quality Assurance

Audits

Stakeholder influence

Project coordination

English fluency

Education

Bachelor's degree in life sciences

PM Certificate (PMP/PRINCE2)

Job description

Ipsen Biopharm Ltd in the UK is seeking a Clinical Quality and Compliance Lead to steer quality and regulatory compliance across Ipsen clinical trials. You will partner with Head Site Management and Monitoring and TA Leads to ensure adherence to Quality Standards and SOPs while sustaining inspection readiness.

The role demands independence, strong communication, and a proven ability to drive continuous improvement within Clinical Development Operations.