Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27622
QA for QC process
Contracting – Brabant Wallon
Your responsibilities: GENERAL QA ROLE
Using a Risk Based Approach, ensure that PSQC Processes & Operations are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Policies & Procedures
Drive quality leadership and provide technical expertise on compliance strategy.
Communicate processes requirements effectively across functional areas.
Promoting culture of quality, operational excellence and “SOSD” (See it, Own it, Solve it, Do it) attitude within Patient Supply Quality Control.
Deliver general cGMP training and effective coaching on QMS to relevant stakeholders.
Communicate compliance status and issues to appropriate organizational levels.
Support regulatory inspections/audits, providing dynamic assistance to SME’s.
PATIENT SUPPLY QUALITY CONTROL PROCESSES
Participate in the improvement of the PSQC processes
Ensure adequate coaching and training of relevant stakeholders on the PSQC processes
Oversee critical global activities to ensure analytical operations are conducted in accordance with Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH)
Manage and follow-up of Deviations, OOS, Failure Investigations, Change Control, Qualification/Validation, Compliance Audit activities, Stability program, Lab Critical Materials, and documentation approval related to the PSQC Processes & Operations.
Implement and maintain adequate Quality & Compliance indicators and communicate results to appropriate levels of the organization
CONTINUOUS IMPROVEMENT
Identify, coordinate and support opportunities for improvement and operational excellence projects in response to business needs, technical changes, risks, audit observations and regulatory requirements.
Lead or co-lead internal quality spot checks/audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP.
Conduct or support Quality Reviews exercises (e.g. Management/Product Reviews, etc)
Identify, coordinate and support Continuous Improvement projects (LEAN, 6-Sigma, Green belt and others) with QC management to enhance quality KPI’s and product/process quality.
Your profile:
Strong knowledge and proven experience in Quality Control and applicable regulations
Proven understanding of QC processes: stability studies, material management, specification management.
Experience with Quality Management System and Internal/External Auditing
Ability to balance multiple priorities, projects, provide leadership and prioritization, and work with minimal supervision
Excellent team player attitude with excellent interpersonal relationships and communication skills
Fluent in French and English
Our offer ? 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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27581
Knowledge Management Expert
Contracting – Brabant Wallon
Your responsibilities: The Knowledge Management Expert plays a key role in ensuring that the Quality Management System (QMS) remains fully aligned with applicable GxP regulations and that critical knowledge is efficiently captured, structured, and shared across the Quality organization. The role is responsible for mapping regulatory requirements to internal QMS policies and procedures, developing and maintaining a repository of regulations and regulatory intelligence, overseeing compliant implementation within the QMS, and enabling the effective flow of actionable knowledge across Quality.
Regulatory Mapping & Compliance Alignment
Systematically map global and regional GxP regulations, guidelines, and standards to internal Quality policies, processes, and procedures.
Identify gaps, overlaps, and misalignments between regulations and internal documentation; collaborate with QMS Process Owners to drive remediation.
Ensure traceability between regulatory requirements and QMS documents through structured mapping tools or frameworks.
Monitor changes in relevant regulations and proactively evaluate their impact on the QMS.
Regulatory Repository Ownership
Build, maintain, and continuously update a centralized repository of all applicable regulations and guidelines (e.g., EU, FDA, ICH, PIC/S, EMA, local authorities).
Establish governance for regulatory document lifecycle, version control, and archiving.
Provide Quality teams with timely access to the most current regulatory information and insights.
QMS Oversight & Implementation Monitoring
Maintain oversight of how regulatory requirements are embedded across the GxP QMS.
Develop and track KPIs or dashboards that measure the completeness and accuracy of regulatory implementation.
Support internal audits, inspections, and assessments by providing clear regulatory mapping and QMS insights.
Partner with Quality Systems, Compliance, and Process Owners to ensure adherence to evolving regulatory expectations.
Knowledge Sharing & Organizational Learning
Design and implement strategies, processes, and tools to support the effective flow of Quality knowledge across functions.
Develop user-friendly summaries, guidance documents, and knowledge assets to promote understanding of regulatory expectations.
Facilitate communities of practice, learning sessions, and cross-functional knowledge exchanges.
Promote a culture of knowledge stewardship and continuous learning within Quality, eventually expanding these capabilities to wider functions.
Your profile:
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Engineering, or related field.
Strong experience in GxP Quality Assurance, Quality Systems, Regulatory Affairs, or related domain.
Solid understanding of global pharmaceutical regulations (e.g., EMA, FDA, ICH).
Experience with QMS frameworks and documentation systems.
Fluency in French & English.
Nice to have
Background in knowledge management, information architecture, or process excellence.
Experience with digital knowledge tools (e.g., regulatory intelligence databases, document repositories, QMS platforms).
Familiarity with change management and effective communication strategies.
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27502
QA Systems Officer Utilities
Contracting – Brabant Wallon
Your responsibilities: General QA Role
Ensure compliance with all relevant regulatory requirements
Organize adequate quality oversight on GMP documentation and activities.
Promote leading and proactive management of deviations, corrective and preventative actions and change controls.
Actively participate to the quality governance in place within the organization.
Ensure appropriate quality indicators are monitored (both leading and lagging) and adhered to.
Ensure escalation of significant/critical quality problems to the appropriate levels of management following the standards set by the QMS.
Participate in the preparation for regulatory inspections, providing direct support to system owners and main customers during inspections.
Promote strong communication within Quality teams and strive for reducing variability to aim for One Quality Voice.
Foster a culture of quality, compliance, and continuous improvement within the organization.
Beltech Utilities support
Together with BIM Teams, ensure direct follow-up of Compliance Audit activities, Deviations, Failure Investigations, Change Control, Qualification/Validation activities and associated documentation approval.
Drive the identification of opportunities for improvement, development and implementation of quality and operational excellence projects in response to business requirements, technical changes, identified risks, audit observations and regulatory requirements.
Lead or co-lead internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP.
QA follow-up of utilities/Beltech related projects and project management.
Using a Risk Based Approach, ensure that all Utilities, HVAC & Cleanroom Systems used Pharma & Injectable, T2, T4 and related supporting services are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Corporate Policies & Procedures
Back up fonction
The position can act as back-up for his direct colleagues or for his manager according to the Manager 's instructions and after appropriate training
Your profile:
Master's degree in a relevant field (e.g., Engineering, Science or a related discipline).
Experience in a regulated pharmaceutical environment or other life science or health related field is mandatory
Experience with Quality Management Systems and Auditing is an asset
Fluent in French, very good level in English is required
Affinity for Quality & Compliance and worldwide regulations pertaining to cGMP regulations pertaining to Pharmaceuticals & Medical Devices
Team player with good interpersonal relationships and communication skills
Our offer ? 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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27448
Documentation Management Expert
Contracting – Brabant Wallon
Your responsibilities: Role Purpose The Documentation Management Expert (QMS Transformation) plays a key role in a cross‑functional program aimed at the end‑to‑end transformation of the Quality Management System (QMS). The role is responsible for designing the future‑state QMS documentation architecture, including document hierarchy, metadata model, lifecycle processes (including translation), and governance, ensuring alignment with GxP regulations, industry standards, and internal quality strategy. This position operates in a project context, focusing on definition, design, and standardization, and provides the foundation for future implementation within electronic document management systems (EDMS). Key Responsibilities
QMS Documentation & Hierarchy Design
Define the future-state document hierarchy for all QMS procedural documents, including Governance & Procedures, Quality Manual, Policies, SOPs and SOP-Ais, Standards and User Guides-A
Establish clear document categories, relationships, and dependencies across the QMS.
Ensure alignment between the document hierarchy and ICH Q10, GxP, ISO standards, and internal quality governance principles.
Metadata Model & Document Taxonomy
Design and document a standardized metadata framework for QMS procedural documents, including : Naming conventions, Versioning rules, Classification attributes, Ownership and governance fields
Define metadata requirements to support: Searchability and usability, Regulatory traceability, Reporting and KPIs, EDMS configuration and automation
Collaborate with Quality Systems and IT to ensure metadata design is system-ready.
Document Lifecycle & Translation Process Design
Define end-to-end lifecycle processes for QMS procedural documents, including: Creation and drafting, Review and approval, Distribution and effective use, Periodic review and revision, Archival and obsolescence
Design and document translation workflows, including: Trigger points for translation, Language scope and prioritization, Roles involved in translation review and approval, Version alignment between source and translated documents
Ensure lifecycle processes are inspection-ready and auditable.
Roles, Responsibilities & Governance (RACI)
Define and document clear roles and responsibilities for all stakeholders involved in QMS procedures, including: Authors, Reviewers, Approvers, Document owners, Quality governance bodies, Translation contributors
Develop RACI models for different document types (Policy, Quality Manual, SOP, SOP-AI, Standard, User Guide).
Ensure consistency of responsibilities across functions and geographies.
Process Design, Alignment & Continuous Improvement
Lead workshops and working sessions to: Assess current-state documentation practices, Identify gaps and inconsistencies, Align stakeholders on future-state standards
Translate project outputs into clear, usable process documentation and guidance.
Define success criteria and KPIs to measure the effectiveness of the future documentation framework.
System Readiness & Implementation Support
Provide business and functional requirements to support implementation of the future-state model in EDMS (e.g. Veeva Vault).
Support validation, user role definition, and data integrity considerations linked to the new documentation framework.
Ensure design decisions support scalability, automation, and long-term sustainability.
Change Management & Enablement
Develop guidance materials, templates, and standards to support adoption of the new QMS documentation framework.
Support communication and training strategies for impacted stakeholders.
Act as a subject-matter expert and advisor throughout the transformation program.
Your profile: Experience, Skills and Knowledge
Strong knowledge of GxP, ICH Q10, ISO 9001, and regulatory requirements related to documentation and data integrity.
Experience with document control processes and QMS frameworks in the pharmaceutical or biotech industry.
Hands-on experience with EDMS platforms (e.g., Veeva Vault)
Solid understanding of document lifecycle management, version control, and procedural governance.
Proven ability to design, optimize, and govern quality processes.
Used to Microsoft 365 suite.
Education & Background
Master’s degree in Sciences, Pharmacy, or a related field.
3–7 years of experience in documentation management, quality systems, or related quality roles in the pharmaceutical industry.
Fluent in French & English
Our offer ? 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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27302
Vendor Quality Lead
Contracting – Brabant Wallon
Your responsibilities: We are looking for a Vendor Quality Lead to reinforce the R&D & Pharmacovigilance Vendor Quality team. The role is needed to support GCP-focused vendor qualification activities, quality agreements setup, and vendor oversight, especially due to a current backlog of agreements and increasing number of GCP vendors.
Managing GCP vendor qualification activities.
Handling the setup, review, update and closure of Quality Agreements (priority scope).
Proven experience in vendor qualification / vendor management.
Solid experience in Quality Agreements lifecycle management.
Knowledge of regulatory requirements (EMA/FDA/ICH).
Experience with risk‑based oversight and CAPA lifecycle.
Fluent English & French.
Ability to work with digital tools and comfortable with technological processes.
Strong professional judgment, ability to act independently and manage complex situations.
Nice to have
Experience with Digital/IT systems, data integrity, IT validation, eClinical tools.
Legal/paralegal background is an asset for Quality Agreement work.
Experience with AI‑driven or digitalization initiatives.
Vendor management experience in additional GxP areas (but not GMP/GDP profiles).
Our offer ? 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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27277
ELN Business Analyst & Developer
Contracting – Brabant Wallon
Your responsibilities:
Business Analysis: conduct stakeholder interviews, process mapping, and current state assessments across CMC Dev laboratories to translate & align needs into clear requirements or user stories, and testing scripts / criteria.
ELN template Design & Development: Apply established processes & style guide to design and configure ELN experiment templates, forms, calculation sheets, workflows, approval steps, audit trails, etc.
ELN structured data structuration: Configure data mapping according to CMC data models ensuring data/metadata schemas are aligned to FAIR principles and scientific and industry domain standards
Optimize usability and search/discovery/re-usability (naming conventions, taxonomies, tagging, template reuse, Inventory), & integration with other computerized systems
Ensure fit for purpose of Digital Operations solutions, and solution & business readiness for implementation – further support change management by monitoring the adoption and performance of newly implemented solutions
Deliver process and solutions documentation, datasets and trainings
Contribute to solutions lifecycle with change requests, impact assessment and continuous improvement
Your profile:
Hands-on expertise configuring and developing within IDBS E‑WorkBook (on premise or Cloud) or similar ELN solution
Hand-on experience and strong understanding of CMC Development laboratory workflows (small molecules, biologics, analytical development, sample & inventory management)
Business Analysis & Product Skills with demonstrated proactiveness, curiosity, analytical and self-reliant mindset
Knowledge of regulatory requirements and quality standards in the biopharmaceutical industry is a plus
Excellent communication, interpersonal and facilitation skills
Continuous improvement and customer-centric thinking, but balanced with an ability to challenge legacy landscape
Our offer ? 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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27275
Qualified Person
Contracting – Brabant Wallon
Your responsibilities: A typical day involves hands‑on operational QA/QP work, including:
Batch release & certification of APIs, excipients, primary packaging, bulk products (tablets & injectables), and final packaged products.
Market complaint handling.
Managing deviations, investigations, CAPAs, recalls, change controls, retests, rework/reprocess, and approval of PQRs/LQRs.
Interacting daily with production teams on the shopfloor (no makeup/jewelry allowed in production areas).
Reviewing and approving procedures in the QP activity scope.
Supporting internal audits, client audits, and inspections.
Ensuring products meet GMP standards and regulatory/MA dossier requirements.
Being reactive to production needs while also having the authority to block batches when needed.
Your profile:
Ideally 5 years relevant experience
Belgian Qualified Person (QP) number – mandatory and non‑negotiable.
Industrial pharmacist degree.
Operational mindset: enjoys being on the shopfloor and reacting swiftly to production realities.
Strong French communication skills (native or fully fluent) + good English for interactions with global teams.
Ability to work under pressure and remain supportive yet firm, especially when blocking non‑compliant batches.
Strong team spirit, collaborative attitude, ease of contact with multiple departments.
Willingness to learn, follow procedures, apply GMP, and avoid taking risks beyond their level of expertise.
Nice to have:
Previous experience in GMP/QP activities, QA, Production or QC.
Experience in packaging operations.
A personality that adapts well, avoids conflict, and fits a collaborative culture.
Our offer ? 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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27237
BMDS Analytical Scientist
Contracting – Brabant Wallon
Your responsibilities: Context The SNC DEV department works on clinical-stage molecules. The team focuses on BMDS / Biological Method Development (bio-methods). Main techniques used in the team:
Contribute to method development and method validation
Work in pairs or small groups (min. 2 people on each validation)
GMP Documentation:
Ensure full compliance with GMP requirements
Complete all associated test documentation
Potentially contribute to drafting protocols and reports (depending on mission duration and autonomy)
Your profile:
Hands-on experience in at least 1–2 of the following techniques: ELISA (binding / potency / HCP), Cell-based assays, qPCR, dPCR
Previous GMP experience
Experience in method development and/or method validation is highly valued
Strong troubleshooting mindset and scientific rigor
Fluency in French & English
Nice-to-Haves
Combined experience in QC and development
Bioanalytical scientist with hands-on experience in key techniques, able to quickly be active in the lab, autonomous on experiments yet collaborative in interpretation and documentation.
Our offer ? 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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
