Braine-l'Alleud, Région wallonne, Belgique Archieven

Vendor Quality Lead

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).
Supporting risk‑based vendor oversight: governance meetings, issue escalation, documentation follow-up.
Acting as QA point of contact for deviations, investigations, audit observations related to assigned vendors.
Ensuring inspection readiness and compliance with GCP, EMA/FDA/ICH expectations.
Collaborating with internal stakeholders (Quality Leads, Global QA, Procurement, Legal, IT/CSV).
Interacting directly with vendor organizations for performance, compliance and governance.
Driving continuous improvement and contributing to harmonization initiatives.

Your profile:

Minimum 10 years of relevant experience.
Strong seniority is required: candidates with 5–6 years of experience will not meet the expected level of expertise.
Strong GCP background + clinical trial management understanding.
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]

ELN Business Analyst & Developer

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
Implement or coordinate & monitor development, testing, issues/defects identification, prioritization & fixes
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

Qualified Person

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.

BMDS Analytical Scientist

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:

Potency assays (binding ELISA, cell-based assays)
Residual HCP ELISA
qPCR / dPCR
Protein A and other bioanalytical methods

Key Responsibilities
Laboratory Activities (priority):

Perform analytical tests in the laboratory
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.

Head of External Clinical Supply Quality

Location: Braine-l'Alleud, Région wallonne, Belgique
Job #27041

Head of External Clinical Supply Quality

Contracting – Brabant Wallon

Your responsibilities:
Operational

Provide timely and efficient GMP/GDP IMP Release function to all relevant project activities related to the development of the pipeline projects (included all relevant activities for IMP release: label approval, batch record documentation, etc…).
Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health and safety, etc.
Participate in the management of QA through active participation in QA forums and other meetings.
Support in-licensing activities by providing Quality Assurance expertise for the evaluation of new project opportunities including participation in due diligence activities.
Support the systems and processes in place for the appropriate documentation of the company development activities and to maintain them in a manner compliant with regulatory and corporate requirements.
Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house).
Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement).
Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions.
Provide support in the evaluation of Temperature excursions for IMP.
Management of Quality Complaints of IMP
Participate in/coordinate escalation of quality topics linked to IMPs supplies
Ensure active participation in the selection, evaluation, approval and maintenance of Vendors for IMP activities, including leadership or support to conduct appropriate audits.
Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…)
Ensure CMO (packaging and distribution vendors) quality documentation is accurate and up-to-date, by editing and reviewing quality agreements
Contribute the preparation of audits (internal/external, regulatory inspections)
Lead internal audits / Self-Inspections

Process

Ensure that all review and release, manufacturing and packaging operations are appropriately compliant with applicable regulations (EMEA, FDA, DEA, MHRA, etc. where relevant).
Support the Head of Clinical Supply Quality in ensuring an acceptable outcome of all audits and inspections, especially those by government agencies, as they pertain to Process Support and Package Development practices (where relevant), equipment, and facilities.
Actively participate in identifying, developing and implementing local quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements by encouraging others to seek opportunities for different and innovative approaches to addressing problems and developing solutions.
Ensure Clinical Supply Quality processes directly support Technical Operations and development partner goals and objectives.
Review and QA approval of deviations, change controls and complaints.

Team

Ensure Staff are managed appropriately, have clearly defined roles, are appraised on an annual basis, have clear objectives, work in accordance with HSE and corporate policy requirements and are developed and trained to meet the need of the business and professional career development.
Oversee resolution of staff-related performance issues.

Your profile:

Master’s degree in Sciences
Certified auditor by official authorities is an asset

Technical Expertise:

Excellent knowledge of cGMP and relevant regulatory requirements (e.g., US, European, Japanese).
Extensive experience in a pharmaceutical regulated environment.
Must be knowledgeable in QA and technical requirements of pharmaceutical development processes.
A complete understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
Experience in conducting customer/vendor audits and managing regulatory inspections
QA/compliance experience in manufacturing, facility operation, and quality systems. Areas of expertise should include compliance, quality assurance, quality control, validation, technical services, and an in-depth knowledge of at least one scientific discipline related to pharmaceutical sciences.

Leadership & Management Skills:

Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments.
Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.
Be able to coach/train/mentor colleagues and deliver training within area of expertise and assist with the development of top talent.
Root cause and risk management/assessment skills.
Must be fluent in English and French, other languages are a bonus.

Qualified Person

Location: Braine-l'Alleud, Région wallonne, Belgique
Job #27018

Qualified Person

Contracting – Brabant Wallon

Your responsibilities:
We are looking for a Qualified Person (QP) starting early January 2026 for a 6-month mission. The position is onsite only (no homeworking). The QP will be responsible for release activities related to packaging (tablets and injectables), complaint management, procedure/document review, and additional QA tasks.

Oversee and ensure compliance of operations related to raw materials, bulk, and finished pharmaceutical products with national/international regulations and quality policies.
Make batch release, rejection, or rework decisions.
Manage quality deviations, investigations, CAPAs, market/client complaints, recalls, and change controls.
Review and approve Product and Line Quality Reviews.
Draft, review, and approve procedures within the scope of QP activities.
Provide QA support to defined projects, especially those linked to release activities.
Participate in internal audits, client audits, and inspections.
Maintain effective communication with stakeholders and production/lab teams.

Your profile:

A minimum of 3 years of similar experience in GMP, manufacturing, and QP roles is required
Industrial Pharmacist degree with a valid QP number (legal requirement).
Experience in the pharmaceutical industry is mandatory.
Impeccable ethics and the ability to make independent decisions.
Fluency in French (working language onsite and for procedures) and English (for handling complaints).
Knowledge of packaging release activities (tablets and injectables) is a strong asset.
Nice to have:

Experience with international GMP regulations.
Experience in Quality Assurance, Production, or Quality Control.
Problem-solving skills and the ability to propose constructive, innovative solutions.
Experience with audits and regulatory inspections.

QC Specialist

Location: Braine-l'Alleud, Région wallonne, Belgique
Job #26971

QC Specialist

Contracting – Brabant Wallon

Your responsibilities:
The recruitment is to support a complex issue related to PEG, in collaboration with a QC specialist.
The work involves technical investigations on polymers, with connections between current analyses, methods, and validations.

Follow-up on deviations and quality issues related to PEG.
Analyze and understand unusual results.
Collaborate with regulatory specs, analytical development, method redesigns, transfers, and production.
Participate in quality committees on Tuesdays and Thursdays.
Use analytical techniques (HPLC, GC, IR, NMR) and software tools (Empower, Cromeleon).

Your profile:

Pharmaceutical experience (submission files, regulatory knowledge).
Proactivity, autonomy, ability to raise issues and suggest solutions.
Strong skills in organic and analytical chemistry (HPLC, GC).
Fluent in French and proficient in English (for international meetings).
Understanding of production processes and their analytical impact.
Master’s degree or technician with 5+ years of experience.

Nice to Have:

Familiarity with the lab and internal techniques.
Experience handling quality deviations.
Knowledge of Empower or Cromeleon.
Additional skills in IR, NMR.

Internal Operations Quality Partner

Location: Braine-l'Alleud, Région wallonne, Belgique
Job #26936

Internal Operations Quality Partner

Contracting – Brabant Wallon

Your responsibilities:
The role is within the Clinical Supply Quality team, focusing on packaging and labeling for clinical studies. The position is critical for ensuring quality systems and compliance in the production, release, and distribution of Investigational Medicinal Products (IMPs) for clinical trials.

– Review of batch records (both electronic and paper).
– Review and release of labels.
– Release of warehouses and production consumables specification.
– Update of CEC (Controlled Environment Conditions).
– System-related activities: deviation review, CAPA (Corrective and Preventive Actions), change control.
– Temperature excursion management.
– Validation activities related to computer design systems.
– Documentation review for operational production activities.
– KPI realization based on specific requests.
– Participation in audits, regulatory inspections, and vendor management.
– Support for qualification, validation, and maintenance of equipment and facilities.

Your profile:
– 3 to 5 years of relevant experience required.
– Pharmaceutical experience is essential; QA/compliance experience in a pharmaceutical regulated environment.
– Proficiency in Excel (KPI creation, pivot tables).
– Hands-on operational QA experience is important and will make a difference.
– Good knowledge of cGMP and relevant regulatory requirements (e.g., US, European, Japanese).
– Technical affinity (e.g., point of contact for equipment validation).
– Dynamic, energetic, and communicative personality, able to challenge and express opinions.
– Fluency in English and French.
– Preferably a Master’s degree in engineering or similar for the right mindset.
– Ability to function with minimal supervision, strong organizational and analytical skills.
– Fact-based decision-making and problem-solving skills (failure investigations, risk analysis).

—- No QP (Qualified Person) number required, but QP training is a plus.

Nice to Have:
– Certified auditor by official authorities.
– Eligibility to act as a QP in the EU.
– Experience in leading internal audits/self-inspections.
– Familiarity with regulatory submissions and CMC (Chemistry, Manufacturing, and Controls) documentation.

Technical Assistant & Project Manager

Location: Braine-l'Alleud, Région wallonne, Belgique
Job #26702

Technical Assistant & Project Manager

Contracting – Brabant Wallon

Your responsibilities:

Actively participate in technology transfer and upscaling projects at CMOs.
Represent the company in projects managed by CMOs.
Collaborate with internal teams (quality, technical, regulatory, manufacturing).
Review and approve validation protocols and reports.
Monitor timelines, activities, budgets, and ensure regulatory compliance.
Manage deviations, change control, and CPV (Continued Process Verification).
Provide technical support and critical insight on sterile operations (compounding & filling).

Your profile:

Experience in sterile pharmaceutical environments (syringe/vial filling).
Knowledge of technology transfers.
Project management skills.
Quality mindset (QA).
Fluency in French & English.
Ability to work with external partners (CMOs).
Autonomy, integrity, and influencing skills.

Nice to Have:

Experience in validation, deviation management, CPV.

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]