Site Conformance Expert | Life Science

Capgemini Engineering; Wallonië; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Career acceleration programs

Continuous feedback

FlexAbroad

Job summary

Capgemini Engineering is seeking a Site Conformance Expert to bridge operations and regulatory affairs, ensuring compliance across Manufacturing and Quality Control streams. You will oversee regulatory dossiers, respond to health authority questions, and drive alignment with evolving requirements.

The role requires a Master’s in a related field and at least 3 years in QA within pharma or life sciences, with strong GMP knowledge and English/French fluency.

Qualifications

• Bachelor-level knowledge of GMP and regulatory requirements.
• Experience in regulatory documentation and quality systems.
• Fluent English and French with strong cross-functional collaboration.

Responsibilities

• Ensure regulatory dossiers and health authority responses across production streams.
• Provide regulatory oversight to maintain alignment with evolving requirements.
• Identify compliance gaps and develop mitigation strategies to prevent recalls or delays.
• Collaborate with cross-functional teams to implement and maintain quality systems.
• Support continuous improvement of documentation and quality assurance processes.

Skills

GMP regulations

Quality systems

Regulatory compliance

English-French communication

Education

Master's degree in Pharmaceutical Sciences, Chemistry, Biology, or related field

Tools

eCTD format

Job description

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

Job Description

Your Role

As a Site Conformance Expert within our Quality Assurance team, you will be the vital link between operations and regulatory affairs, ensuring compliance across multiple production streams including Primary, Secondary, Quality Control, and Incoming Materials.

• Ensuring compliance with regulatory dossiers for activities related to Manufacturing Performance Units and Quality Control Departments, through variations and timely responses to health authority questions.
• Providing regulatory oversight within Manufacturing Performance Units and Quality Control Departments to maintain consistent alignment with evolving regulatory requirements.
• Analysing potential compliance gaps and developing effective mitigation strategies to prevent supply issues, delays, or recalls due to misalignment with regulatory files.
• Collaborating with cross-functional teams to implement and maintain quality systems that meet global regulatory standards across all production streams.
• Supporting continuous improvement initiatives to enhance compliance processes, documentation systems, and overall quality assurance performance.

Your Profile

We are looking for a motivated and detail-oriented professional who thrives in a regulated environment and is passionate about quality and compliance.

• You hold a Master's degree in Pharmaceutical Sciences, Chemistry, Biology, or a related field, and bring a minimum of 3 years of experience in a quality assurance role within the pharmaceutical or life sciences industry.
• You have strong knowledge of GMP regulations, quality systems, and regulatory compliance requirements, with hands‑on experience in regulatory documentation including eCTD format and normative documents.
• You are fluent in both English and French, with strong communication skills that allow you to effectively engage and collaborate with diverse stakeholders across departments.
• You are a proactive team player with the ability to manage multiple priorities, work independently, and contribute meaningfully to a high‑performing, cross‑functional environment.

What you'll love about working here

• Career acceleration programs – From associate to leaders and beyond, get support in your career at every stage with award-winning programs such as our leadership development program, Connected Manager, to accelerate your growth and develop your expertise.
• Continuous feedback – We take a human‑centric approach to foster growth and performance. Our performance management tool GetSuccess enables continuous feedback, quarterly check‑ins with managers, and ongoing performance discussions.
• FlexAbroad – Employees in 20+ countries can work abroad for up to 45 days in a 12-month period.