Site Conformance QA Expert — Life Sciences Compliance

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

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.