Site Conformance Expert - GMP & QA in Life Sciences

Capgemini Engineering; Diegem; Presencial; EUR 45 000 - 55 000; Tempo integral

Resumo da oferta

Capgemini Engineering is seeking a Site Conformance Expert within our Quality Assurance team. You will ensure regulatory compliance across Manufacturing Performance Units and Quality Control, acting as the vital link between operations and regulatory affairs.

With a Master's in Life Sciences and at least 3 years in QA, you will oversee GMP and regulatory documentation, including eCTD, and collaborate across functions to strengthen quality systems globally.

Qualificações

• Master's degree in a life sciences field with ≥3 years QA experience in pharma.
• Strong knowledge of GMP, quality systems and regulatory requirements.
• Fluent in English and French with excellent cross-functional communication.
• Proactive team player able to manage multiple priorities in a regulated environment.

Responsabilidades

• Ensure regulatory dossiers and health authority responses across MPU and QC.
• Provide regulatory oversight to align with evolving requirements.
• Analyze compliance gaps and develop mitigation for supply issues or recalls.
• Collaborate with cross-functional teams to maintain global quality systems.

Conhecimentos

GMP knowledge

Regulatory compliance

eCTD knowledge

English and French

Formação académica

Master's in Life Sciences

Ferramentas

eCTD format

Descrição da oferta de emprego

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.

In this role you will play a key role in:

• 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.
  
  

For this role, the gross annual starting base salary is 50.000 euro (full-time). This covers base pay only; any bonuses, incentives, and benefits will be discussed later in the recruitment process. Candidates with additional experience or qualifications may receive a higher offer, determined by objective, gender-neutral criteria and consistent with our pay principles. If a collective labour agreement applies, we will explain the relevant pay terms at the interview stage. Note: We never ask for your current or previous salary during our hiring process.