Senior GCP/GCLP Quality Auditor (Remote)

Ipsen Biopharm Ltd; Greater London; Remote; GBP 60,000 - 90,000; Full time

Job summary

Ipsen Biopharm Ltd. is seeking a Senior GCP/GCLP Quality Auditor (Remote) to lead and manage audits across internal and external partners, in line with regulatory requirements and Ipsen policies. The role involves global travel to conduct audits, attend meetings, and support regulatory inspections.

You will own audit planning, execution, reporting and CAPA oversight, acting as a trusted SME within the Global Quality Audit team and coaching peers to continually improve Ipsen’s audit framework.

Qualifications

• Experience auditing GCP/GCLP environments.
• Lead Auditor certification required.
• Able to travel internationally on short notice.
• Excellent English communication; French a plus.

Responsibilities

• Lead and deliver a combination of risk-based GCP/GCLP audits across internal and external partners.
• Own audit planning, execution, reporting and CAPA oversight.
• Act as a trusted subject matter expert, advising stakeholders and supporting regulatory inspections.
• Coach and peer-review auditors, contributing to continuous improvement of Ipsen’s audit framework.
• Collaborate globally within our Global Quality Audit (GQA) team.

Skills

GCP/GCLP audits

Lead Auditor certification

Global matrix environment

English communication

Education

Scientific/health background

Job description

Senior GCP/GCLP Quality Auditor (Remote)

Company: Ipsen Biopharm Ltd

About Ipsen

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success.

Job Description

We are offering an exceptional opportunity to join a dynamic global team that is developing and enhancing Ipsen’s audit strategy. You will join a team that is responsible for the audits across all GxPs, a team that is passionate about Quality. As a Senior GCP/GCLP Quality Auditor, you will lead and manage audit activities in line with regulatory requirements, company policies and procedures. The role includes global travel to conduct audits and attend relevant meetings as needed.

What you’ll do

• Lead and deliver a combination of risk-based GCP/GCLP audits across internal and external partners
• Own audit planning, execution, reporting and CAPA oversight
• Act as a trusted subject matter expert, advising stakeholders and supporting regulatory inspections
• Coach and peer-review auditors, contributing to continuous improvement of Ipsen’s audit framework
• Collaborate globally within our Global Quality Audit (GQA) team

What you’ll bring

• Strong experience auditing one or more GCP/GCLP environments
• Lead Auditor certification and a scientific or health-related background
• Confidence working independently in a global, matrix environment
• Excellent communication skills in English (French a plus)
• Flexibility to travel internationally (significant travel required)

Why Ipsen

You’ll join a values-driven organisation where we Think Big, Act Together and Execute with Precision, with the opportunity to influence quality standards globally and safeguard patient safety.

Inclusion & Diversity

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace "The Real Us". The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities.

When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us.

If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.