Inspections Lead

Nalys; Waals-Brabant; On-site; EUR 90,000 - 130,000; Full time

Job summary

Nalys is seeking an Inspection Management Lead to join a global quality team at a leading biopharmaceutical company. You will focus on inspection management and readiness to ensure compliance with GVP, GCP, and GLP, coordinating with internal teams and affiliates worldwide.

The role requires hands-on inspection experience, a regulatory mindset, and the ability to unite stakeholders around compliance. Fluency in English is essential; French is a strong asset.

Qualifications

• 5+ years of experience in pharmacovigilance, GVP quality assurance or auditing.
• Hands-on experience with inspections, ideally hosting inspections.
• Experience with global health authorities and PV systems.

Responsibilities

• Drive inspection readiness activities ahead of announced and unannounced inspections.
• Prepare, support and host global inspections, including front room and back room coordination.
• Review documentation to ensure alignment with regulatory expectations.
• Provide quality oversight of pharma systems and processes worldwide.
• Collaborate with cross-functional stakeholders and international affiliates to secure inspection outcomes.
• Contribute to a culture of continuous compliance across the global landscape.

Skills

Pharmacovigilance

GVP quality

Auditing

Inspection readiness

Regulatory liaison

Stakeholder management

English proficiency

French language

Job description

Nalys is a growing consultancy company specialized in high-tech engineering and life sciences. Founded 15 years ago, we partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains.

At Nalys, we believe in combining deep expertise with a human-centric approach — empowering our consultants to thrive and our clients to succeed.

Joining Nalys means becoming part of a collaborative, agile, and forward-thinking team that values excellence, innovation, and continuous growth.

Job Description

As the Inspection Management Lead, you will join a global quality team within a leading biopharmaceutical company.

Your mission will focus on inspection management and inspection readiness, so that the organization stays compliant with global regulatory requirements (GVP, GCP, GLP) and is prepared at all times to welcome health authority inspections.

This role sits at the crossroads of quality, safety and regulatory functions. You will act as a key point of coordination between internal stakeholders and affiliates across the globe, from proactive preparation to the inspection itself.

We’re looking for a quality professional with hands‑on inspection experience, a strong regulatory mindset, and the ability to bring people together around compliance.

The Role & Responsibilities

Working within an international team and in close collaboration with Pharmacovigilance, Regulatory, Clinical and other functions, your responsibilities will include:

• Driving inspection readiness activities ahead of announced and unannounced inspections
• Preparing, supporting and hosting global inspections, including front room and back room coordination
• Reviewing documentation to ensure alignment with regulatory expectations
• Providing quality oversight of pharma systems and processes worldwide
• Collaborating with cross-functional stakeholders and international affiliates to secure inspection outcomes
• Contributing to a culture of continuous compliance across the global landscape.

Skills & Qualifications

• You have a minimum of 5 years of experience in pharmacovigilance, GVP quality assurance or auditing
• You have strong, hands‑on experience with inspections, ideally having hosted inspections yourself
• You have worked with global health authorities
• You have a solid background in GVP compliance and quality assurance
• You are experienced in audit and inspection readiness as well as documentation review
• Your stakeholder management and collaboration skills are excellent
• You are fluent in English, both written and spoken
• Internal or external auditing experience, knowledge of PV systems, vendors and quality management systems, and French language skills are strong assets.

The Recruitment Process

By applying for the “Inspection Management Lead” position, you will go through the following steps in our recruitment process:

• Olivia Braszko, TA Specialist, will analyze your resume and cover letter and schedule a first screening
• You will have a second interview with one of our Technical Experts
• The last interview will be with our Business Unit Director, Jimmy Roousseaux.