Job description
Mission
Join the QA CSV group within a leading pharmaceutical Quality organization to safeguard data integrity across commercial and clinical systems on the Belgian Campus. You’ll serve as the Data Integrity authority, driving compliance, risk mitigation, and cross-site collaboration for small-molecule platforms.
Key Responsibilities
1. Site Data Integrity Leadership
* Partner with SMEs to assess local systems/equipment for DI risks and vulnerabilities.
* Author remediation plans and DI strategies; report to the Site Quality DI Lead.
* Act as the local Process Owner for Data Integrity governance.
2. Cross-Site Collaboration
* Lead the Small Molecules DI Community of Practice: chair multi-site sessions, guide SMEs in system assessments, and manage platform-level data flow mapping/risk assessments.
* Report to the SM Platform DI Lead on remediation progress and compliance status.
3. Compliance & Continuous Improvement
* Stay ahead of global regulations (21 CFR Part 11, EudraLex Annex 11, GAMP, DI guidelines) via training and benchmarking.
* Represent DI during audits/inspections (regulatory, customer, internal).
* Advise engineering/IT teams on DI requirements for new systems, equipment, and processes.
Must-Have Qualifications
* Education: Master’s in a scientific discipline (or equivalent experience).
* Experience: 4–6 years in pharma, including hands-on Data Integrity remediation and Computerized System Validation (CSV).
* Regulatory Expertise: Deep knowledge of cGMP/CSV frameworks (21 CFR Parts 11/210/211, EU GMP Annex 11, GAMP 5, DI guidelines).
* Languages: Fluent in English and Dutch (written and verbal).
* Mindset: Risk-based decision-making, strong ownership, and ability to align quality decisions with business impact.
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.