Senior GCP/PV Quality Auditor (Remote)

Reposted 11 Days Ago
Be an Early Applicant
5 Locations
In-Office or Remote
Senior level
Healthtech • Manufacturing
The Role
Lead GxP audits, manage audit activities, and oversee CAPA processes while collaborating with global teams and advising stakeholders.
Summary Generated by Built In

Title:

Senior GCP/PV 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. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

Senior GCP/PV Quality Auditor (Remote)

Global Quality Audit | Flexible Location

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. The role involves conducting and managing audit activities with applicable regulatory requirements and company policies and procedures. You will be required to travel globally to conduct audits and attend relevant meetings as required.

What you’ll do

  • Lead and deliver a combination of risk‑based GMP/GDP/GCP/GVP/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 GxP 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.

Ready to make an impact? Join Ipsen and help shape the future of global quality. Apply today and become part of a passionate team dedicated to excellence and patient safety.

#LI-REMOTE

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.

Skills Required

  • Strong experience auditing GxP environments
  • Lead Auditor certification
  • Scientific or health-related background
  • Excellent communication skills in English
  • Flexibility to travel internationally

Ipsen Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Ipsen and has not been reviewed or approved by Ipsen.

  • Healthcare Strength Health coverage is described as comprehensive, with broad medical, dental, and vision offerings. Company materials emphasize a wide-ranging package that supports overall wellbeing.
  • Retirement Support Retirement programs are highlighted with a competitive 401(k) match and access to an employee stock purchase plan. These elements are frequently cited as strengths in the package.
  • Parental & Family Support Family support includes paid parental leave and company-provided backup child and elder care. These programs complement core benefits and add practical day-to-day value.

Ipsen Insights

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The Company
Berkeley Heights, NY
5,848 Employees

What We Do

Ipsen is a French leading global mid-size biopharmaceutical company headquartered in Paris, France focusing its efforts where unmet medical needs are greatest. Ipsen develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Rare Disease and Neuroscience. We have over 5000 employees worldwide and our medicines are registered in more than 100 countries, with direct commercial presence in over 30 countries. Ipsen has 4 global R&D hubs and 3 pharmaceutical development centers around the world

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