QA Compliance Expert (m/f/d)

Tasks :

• Deliver coaching sessions to SMEs and audit teams to ensure preparedness for inspections and self-inspections.

• Define and implement the self-inspection schedule using a risk-based approach; in collaboration with site leadership.

• Performed gap assessments on new/revised global procedures.

• Ensure communication and coordination with all departments

• Collaborate with the broader Biologics network to benchmark best practices and ensure alignment across sites.

• Plan and coordinate SLT Gemba

• Act as the local data integrity champion

• Ensure Data Integrity on site through a strong collaboration with Global Teams and other facilities.

• Availability outside regular hours during audits or critical events.

• Strong autonomy, rigor, communication, and cross-functional collaboration skills.

• Prepare, analyze and present key topics related to the compliance activity at the Quality Council

• Provides Compliance Support to Partners

• Act as back-up for the Quality Compliance and Systems Expert (inspection readiness, compliance topics)

• Support the preparation of GMP audits by contributing to document reviews and providing QA input in collaboration with Quality Compliance Expert.

Qualification:

• University degree in technical/ scientific discipline such as biochemistry, chemistry, engineering or equivalent

• At least 7 years of experience in the biotechnology and/or pharmaceutical industry, preferably both

• Strong knowledge of a GMP environment

• Good understanding of manufacturing, laboratory testing and warehousing operations applicable to biological products.

• Good understanding of Good Data and Documentation Practices (GDDP) and Data Integrity principles. Experience in creating, reviewing, and revising Standard Operating Procedures (SOPs) and technical documents.

• Experience supporting regulatory inspections and audits.

• Familiarity with risk management tools and methodologies (e.g., FMEA, root cause analysis).

• Proficiency in French and English (minimum B2 level or equivalent).
• Proficiency in using electronic quality management (e.g., Veeva Vault, TrackWise).
• Proficiency in Microsoft Office tools, including Word, Excel, Power Point and SharePoint.
• Proficiency with data analysis and reporting tools, including Power BI.

• Occasional travel may be required (e.g., to other sites for alignment or training)

• Ability to access all site areas

• Availability outside regular hours during audits or critical quality events.

• Strong autonomy, rigor, communication, and cross-functional collaboration skills.

Requirements:

Start : 16.03.2026