Brabant Wallon – Contracting
Our partner is looking for a R&D and Pharmacovigilance Digital Quality lead to join its team. This international company is well known for its pharmaceuticals.
Our partner is looking for a R&D and Pharmacovigilance Digital Quality lead to join its team. This international company is well known for its pharmaceuticals.
R&D and Pharmacovigilance Digital Quality lead
Description de la fonction
GxP System & Technology Compliance
End-to-End Data Integrity (DI) Governance & Compliance
- Ensure GLP, GCP, GVP and GRA business systems are fully compliant with regulatory expectations (e.g. OECD, ICH, GVP) and internal digital governance requirements.
- Maintain and evolve the compliance framework for GxP-relevant systems (policies, SOPs, guidance).
- Provide QA insight during system selection, onboarding, validation, and ongoing oversight.
- Support investigations, deviations, CAPAs, and inspection-readiness activities related to DI or system failures, ensuring completeness and alignment with regulatory expectations.
- Oversee the validation and lifecycle control of external computerized systems used by CROs or third-party service providers, ensuring they meet internal quality and regulatory expectations.
- Collaborate with other QA teams and business stakeholders to define validation requirements, risk-based controls, and deliverables for external systems that generate or process GxP data.
- Ensure appropriate documentation (URS, validation packages, data flows) is in place for external systems supporting clinical studies and activities.
- Participate in vendor assessments with a focus on system integrity, validation, and compliance evidence.
End-to-End Data Integrity (DI) Governance & Compliance
- Ensure end-to-end Data Integrity across all GxP-relevant data flows, from initial data capture in external partner systems through all transformations, transfers, and integrations into the company-owned environments.
- Work with Computer System QA team and Clinical Operations to ensure that DI controls (including ALCOA principles, metadata management, audit trails, system-to-system data transfer checks, and dataflow mapping) are embedded across the full data lifecycle.
- Assess and document Data Integrity risks associated with externally operated systems and the interfaces linking them to internal systems, ensuring that controls are in place to protect data reliability, and traceability.
- Contribute to the development, implementation, and continuous improvement of DI practices aligned with ICH E6(R3) expectations and EMA guidance on sponsor oversight of computerized systems
Profil
- Bachelor’s Degree required, Master’s degree preferred (IT, Engineering, Life Sciences, or related field).
- Prior experience in Pharmaceutical R&D (sponsor or CRO environment) with exposure to GxP computerized systems.
- Solid knowledge of GLP, GCP, GVP and GRA regulatory frameworks and associated expectations for computerized systems (e.g., OECD GLP, ICH E6(R3), EU GVP Module I/IX).
- Strong understanding of Computerized System Validation (CSV) principles, including risk-based approaches and system lifecycle activities.
- Familiarity with data integrity requirements (ALCOA , metadata, audit trails, dataflow controls) and regulatory expectations for end-to-end data governance.
- Experience in managing deviations, investigations, and CAPA activities within at least one GxP domain.
- Ability to assess external vendor systems for compliance, validation status, and DI risk, including interpretation of validation packages and supplier documentation.
- Ability to interpret complex data flows across external and internal systems and identify data integrity risks across the full lifecycle.
- Strong critical-thinking and problem-solving skills with the ability to apply regulatory expectations to practical system scenarios.
- Ability to work effectively with cross-functional teams to align expectations and ensure consistent compliance across shared systems.
- Strong communication skills, able to convey quality concepts and DI/CSV requirements to diverse technical and non-technical stakeholders.
Offre
- Voiture d'entreprise
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.