Job Location: BRAINE-L'ALLEUD

• Location: Braine-L'alleud
• Job #25630

Global Quality Auditing – Business Operations Partner
Contracting – Brabant-Walloon

Responsibilities?

• Monitor the progress of plans and projects, GQA performance, and compliance through
• meaningful KPIs. This will boost operational efficiency and agility. Ensure and track appropriate
• data entry performance of audit reports and CAPAs in the Veeva audit system.
• Enable insights for the company through data collection, entry, and analysis in the audit
• management tool (e.g., trending, KPIs, etc.).
• Curate data, including quality checks of audit management tool as needed, for
• KPIs/metrics on performance and information on trending.
• Ensure maintenance and improvement of quality of critical data within the Quality
• Management System (includes data entry of audit related information and data
• monitoring).
• Make extractions from the audit management tool for data inclusion within internal
• reports as well as to meet Health Authority requirements (e.g., Pharmacovigilance
• System Master File (PSMF)
• Act as a key point of contact in Global Quality Auditing & Compliance team for the audit management tool.
• Provide support to the Global Quality Auditing team regarding Documentation management within the controlled documents system.
• Identify improvement needs and implement consistent quality processes and systems across auditing quality units to promote standardization and simplification, thereby enhancing efficiency.
• Propel positive change and improvements across the auditing units by enhancing people's skills and processes.

Your profile?

• Master Degree (preferred) or Bachelor’s Degree
• 3-5 years of experience in the pharmaceutical/biotechnology area and/or Quality-related areas.
• Experience in the pharmaceutical industry within regulated areas (e.g., Research, Laboratory, Clinical, Pharmacovigilance, Manufacturing, …) and/or Quality Assurance expertise is a plus.
• Experience with Qlik Sense, Sharepoint, Teams, Veeva Systems is preferred.
• Fluent in English
•  Regulatory & Technical Knowledge: Must be highly knowledgeable in the global pharmaceutical industry, including the interpretation and application of applicable GxP regulations in complex situations, knowledge of current and future trends in the industry and a deep understanding of major competitors/industry peers.
• Demonstrates curiosity and learns from the experience of success and failure
• Proactively shares knowledge with others in order to affect continuous improvement.
• Takes initiatives and works towards delivering results
• Challenges self and others on value creation
• Encourage quality mindset, constructive and holistic approach
• Ability to anticipate, influence & apply regulations to Quality Management System to ensure effective interpretations that support decision-making on current and future solutions to improve patients’ lives.
• Ability to independently and critically evaluate quality management systems and quality operations in support of Quality culture and operational output, balancing weaknesses against requirements and expectations.

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
• Job #25670

Bio Manufacturing Science and Technology (MSAT) Quality Lead

Contracting – Brabant Wallon

Your responsibilities:

• Establish and build a network with the company key stakeholders in relation to Internal and External MSAT for Bio Drug Substances and Drug Products.
• Provide expert QA advice, support and management for technical operational QA and general QA matters associated with Internal & External Bio MSAT, with the following focus:

• Troubleshooting and ensure issues are resolved in accordance with policies and procedures
• Process improvement and life cycle management strategy within regulatory file boundaries
• Process industrialization and Technical transfers within commercial manufacturing facilities
• Complex investigations and CAPA plans implementation
• Process validation oversight and continuous process verification (CPV)
• Analytical method transfer and troubleshooting support.

• Build, establish and develop a governance model and process for Quality oversight of Internal and External MSAT for Bio Drug Substance and Drug Products which fosters continuous quality process improvement, optimized resource utilization and key indicator based performance monitoring
• Support assignments associated with the Products, or transversal projects across multiple Products
• Work closely with Global QA teams, Technical Operation Teams and Business stakeholders in an effective and efficient way
• Promote quality best practices throughout the External & Clinical Supply Quality team and where possible business stakeholders. Create as needed simplified, efficient processes and procedures to support the team’s activities.
• Provide support to other team members and assist in the further development of the wider team
• Work collaboratively as part of a wider team and when required deputise for the Head of Bio MSAT Quality and other Bio MSAT Quality Leads
• Support the review and approval of Regulatory Submission sections as needed
• Work in accordance with the company HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development

Your profile:

• Master’s degree in Sciences
• Fluency in French and English
• Knowledge in multiple areas of Biopharma incl manufacturing and analytical testing, including the interpretation and practical application of applicable regulations.
• Excellent knowledge of the Bioceutical industry from a business and technical perspective.
• Must have the ability to manage projects/ activities across global geographies within the area of expertise. Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results.
• 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 Problem solving (Describe the level of “self-starting” thinking required in the for recognising, analysing and solving problems)
• Must have the ability to independently analyse data and information to draw conclusions and make effective decisions.

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
• Job #25492

Logistic Compliance Specialist

Brabant-Walloon – Contracting

Our partner is looking for a Logistic Compliance Specialist to join its team.
Your responsibilities?  

• Ensure Shipping Qualification is in line with the companies sop‘s and applicable referentials & standards (i.e. GDP, USP 1079, …),
• Animate Shipping Qualification project team and ensure shipping qualification deliverables are in line with the overall project milestones,
• Document shipping qualifications and associated documentation,
• Manage associated Change Controls.
• Get shipping Operational Qualification Report approved,
• Get shipping Performance Qualification Report approved ,
• Manage the creation of new datalogger set-up and update associated documentation,
• Ensure proper handling procedure is in place at supplier level,
• Report shipping qualification achievements and planning follow-up to project Core Team.
• Manage project change control(s), including impact analysis, submission to CC board and validation, follow-up in company eQMS…
• Manage Operational Qualification study:
• Write OQ protocol, manage review workflow, integrate comments, manage approval workflow,
•  Coordinate the study with the companies CLO (manage shipment requests, quotation, test execution follow-up, …),
• Write associated OQ report, manage review workflow, integrate comments, manage approval workflow,
• Write PQ protocol, manage review workflow, integrate comments, manage approval workflow,
• Coordinate PQ shipments with the supplier and internal stakeholders (including Global Logistics),
• Write associated PQ report, manage review workflow, integrate comments, manage approval workflow
• Manage datalogger set-up creation (SAP ref., Quality Agreement update, associated QA documentation update…),
• Set-up appropriate handling procedure and update relevant QA associated documentation for Global Logistics operations,
• Provide SME support and training to key stakeholders including supplier, Global Logistics Operations, Quality teams etc,

Your profile?

• Fluent in English,
• Working knowledge of GMP/GDP regulations,
• Proficient with qualification exercises,
• Understands basics of logistics operations,
• Ability to manage the “grey zone”, balance multiple priorities,
• Able to work within an international team environment and good team player.

 

• Location: Braine l'Alleud
• Job #25437

CMC Quality Solutions Specialist
Brabant Wallon – Contracting

Your responsibilities?
As Quality Solutions Specialist you will provide support to a group of CMC Quality Lead professionals relative to Quality Assurance activities associated with the lifecycle management for products commercially available or in late-stage development.

• Product Change Control Committee preparation and change controls follow-up
• Maintenance and lifecycle management of QA product flows
• Audits and Inspection anticipation and readiness
• Product metrics
• Review of Annual Stability Plan
• SOPs and other control documents writing, review and approval as needed
• Building and maintenance of Product QA knowledge (i.e., Product(s) SharePoint(s))
• Risk management and mitigation if applicable (e.g., follow-up on risk actions with QA stakeholders)
• Review and approval of CMC sections linked to regulatory original submissions, renewals or variations during any moment of the lifecycle management of the assigned products as needed
• Preparation and execution of Product launches from QA perspective (support in QA-RA assessment, support in QA activities, complaint readiness, shipping validation) as needed
• Product Quality Complaint Committee preparation and complaints oversight
• Product recall and product escalation meeting preparation
• Annual report (i.e., reporting of change controls to Health authorities…)
• Yearly Biological Product Report

Your Profile?

• Minimum of 3 years working in the pharmaceutical/biologics industry in a quality management position. Operational experience in GMP in Quality, Manufacturing or Quality Control would be an asset
• Fluent and confident use of English
• Knowledge in several areas of the global pharmaceuticals industry, including the interpretation and practical application of applicable regulations.
• Autonomy and adaptability
• Skilled and experienced in operating across cultures and in a multi-cultural environment
• Understanding of CMC Regulatory requirements

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
• Job #25423

HSE Compliance Officer
We are looking for a motivated and experienced individual to join our team in the local support department in Belgium, within the Health, Safety, and Environment (HSE) service. Although the role touches on health and safety, it focuses primarily on environmental aspects. The position involves working on environmental projects and maintaining regulatory compliance across multiple regions (Wallonia, Brussels, Flanders).

The person will be responsible for managing environmental issues, including the “Licence to Operate” for our sites in HQ, Leuven, and Braine, in relation to environmental and urban planning permits. The individual will closely collaborate with the engineering team to ensure the necessary permits are obtained.

The Responsibilities

– Environmental Permits Management (Licence to Operate): Preparation, modeling, and data collection for the environmental and urban planning permits required for site activities
– Regulatory Compliance: Ensure compliance of installations with legal health, safety, and environmental requirements, especially regarding the risks associated with the storage of hazardous materials (CVZO).
– Environmental Projects: Track and manage environmental projects, including internal audits, measurement campaigns, and reporting to authorities.
– Environmental Management System: Maintain and improve our certified environmental management system. Participate in internal audits, measurement campaigns, and manage the administrative data related to environmental services.
– External Collaboration: Work with external consultants and experts to ensure effective environmental management and smooth communication with local authorities.

Skills and Knowledge Requirements

– Scientific Background: Degree in a scientific field with a specialization or relevant experience in environmental management.
– Environmental Management Experience: Experience in managing environmental issues, with good knowledge of local regulations (Wallonia, Brussels, Flanders).
– Administrative Knowledge: Ability to understand and follow environmental regulatory requirements and perform necessary reporting.
– Legislation Knowledge: Knowledge of environmental legislation in Belgium (Wallonia, Brussels, Flanders) is an asset.
– Languages: English is not required, but knowledge of Dutch is a plus, particularly for the Leuven site.
– ISO Certifications: Experience in an environment with a certified environmental management system (ISO 14001) is an asset but not a requirement.
– Flexible Working Hours: This position is a 50% replacement for the sick expert, with flexible hours (Tuesday, Wednesday, and Thursday mornings).
– Remote work is permitted when on-site presence is not required, but there are no fixed remote work days.
Additional Assets:
– Experience with Seveso risk management (hazardous materials storage).
– GMP (Good Manufacturing Practices) certification is a plus, but not required.
– Ability to ask questions and solve problems independently.

Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
 

• Location: Braine-l'Alleud
• Job #25388

Logistics Compliance Specialist

The person will ensure pharmaceutical products are transported from point A to point B under appropriate thermal and technical conditions.

Scope:

• May involve products in launch phases or lifecycle management. As products evolve, new routes, destinations, and regulations must be considered.
• A strong quality mindset is essential since the team is subject to internal and external GDP audits.
• New documentation requirements mean the candidate will need to perform quality management reviews.

The Responsibilities

• Product Shipping Qualification: participate in regular project meetings with global project teams.
• Ensure shipping aspects are appropriately covered in alignment with project goals.
• Quality Activities: prepare for inspections and audits (internal/external). Dedicate time to ensuring compliance with GDP requirements and inspection readiness.
• Team Support: attend regular meetings with the Quality team to provide updates and align priorities.

Knowledge and Skills Requirements

• At least 5 years of relevant experience in supply chain (preferable, but flexible).
• Experience in the pharmaceutical industry is a must.
• A blend of QA mindset and supply chain expertise: working knowledge of GMP/GDP regulations.
• Experience implementing procedural control frameworks.
• Familiarity with audit/inspection protocols.
• Understanding of supply chain fundamentals, from long-term demand planning to patient distribution, including tools, terminology, and techniques.
• Strong team spirit and ability to integrate into an existing team.
• Languages: Fluency in English is mandatory; French is a plus.

Our Offer

Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
 

• Location: Braine-l'Alleud
• Job #25387

QC Equipment Specialist
Join the QC team, working with a substantial analytical equipment park. The role goes beyond just qualification and maintenance of equipment, focusing primarily on the coordination of various activities related to these pieces of equipment. This role is akin to that of an architect, as it requires an overall view of the equipment's lifecycle.

The Responsibilities

• Equipment Management:
  • In the event of a breakdown, identify and coordinate necessary actions with internal and external stakeholders.
  • Follow-up on equipment, install new equipment, and manage related projects.
  • Coordinate with support departments to ensure proper maintenance, qualification, and installation of equipment.
  • Project Management: Track timelines, budgets, and required resources for installation or upgrades of equipment.

 

• Activity Coordination:
  • Serve as the point of contact for different stakeholders: qualification/validation, maintenance, IT, QA, laboratory (end users).
  • Perform testing, when necessary, in collaboration with the laboratory.
  • Ensure smooth execution of projects while adjusting priorities and juggling multiple tasks.

 

• Planning and Monitoring
  • Manage several simultaneous projects, with up to 4 to 5 pieces of equipment to manage per person.
  • Use the Integrate software to track various projects and activities.

Required Skills and Profile

• • Rigorous and Organized: The candidate must be highly structured and able to manage shifting priorities.
  • Multitasking: Ability to work on multiple projects at once, sometimes dealing with urgent changes in priorities.
  • Experience with Laboratory Equipment: Knowledge of analytical equipment in GMP (Good Manufacturing Practices), such as HPLC, UPLC, UV, Infrared, PCR vessels, fridges, and freezers.
  • Familiarity with LIMS, Source, and Integrate systems is a plus.
  • Communication Skills: Ability to understand and write documentation in English (B2 level minimum), as equipment documentation is mostly in English. Ability to communicate with external suppliers and manage international interactions.

Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]

• Location: Braine-l'Alleud
• Job #25357

Research Scientist Regulatory Bioanalysis
Le consultant devra assurer la réalisation dans les meilleures conditions de qualité et de délai, le développement et la validation de processus bio-analytiques automatisés en environnement régulé GLP & GCP (BPL & BPC). Ces processus devront suivre et respecter les règles des Bonnes Pratiques de Laboratoire et les sections applicables des Bonnes Pratiques Cliniques.
Ces processus auront pour but la quantification des analytes présents dans les échantillons biologiques provenant d’études précliniques et cliniques.
La fonction s’appliquera aux points suivants :
À la sélection, à l’implémentation et à la validation (computerized system validation for GLP and GCP activities) d’applications et d’instruments utiles au laboratoire de bioanalyses.
Au développement de méthodes et de processus automatisés, utiles à la gestion et à la manipulation d’échantillons tests provenant de divers laboratoires, services ou départements, ou sous-traitants (études de pharmacocinétique, toxicologie, pharmacologie).

Les Responsabilités

• Assurer de la bonne gestion du matériel et des équipements de laboratoire (maintenance, calibration, qualification), en tant qu’utilisateur, responsable d’appareil ou suppléant.
• Développer des méthodes et des processus bio-analytiques automatisées.
• Être responsable de la validation des applications et des instruments du laboratoire.
• Réaliser les essais au laboratoire, et parfaire sa formation technique et scientifique.
• Prévoir les besoins en produits, réactifs et matériel de laboratoire nécessaires à la réalisation des objectifs qui lui sont confiés.
• Rédiger et revoir des procédures d’opération standards.
• Assurer la conformité aux normes GLP & GCP.
• Veiller au respect des procédures de travail et de sécurité.
• Suivre l’évolution des connaissances dans les domaines techniques et scientifiques qui relèvent de la spécialisation du laboratoire et des objectifs qui lui sont confiés.

Connaissances et Expériences requises

• Une connaissance pratique des normes GLP & GCP.
• Développement de méthodes et de processus.
• Rédaction et revue des procédures.

Notre Offre
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. 

• Location: Braine-l'Alleud
• Job #25352

Analytical Scientist
To strengthen our Analytical Sciences for our client, we are looking for an Analytical Scientist with a strong experience in analytical development, process support and at least hyphenated analytical techniques (Nuclear Magnetic Resonance – NMR). The position is based in our Characterization and Material Sciences department on their site in Braine l’Alleud, Belgium.
In this role, you will contribute to the end-to-end analytical development of our small molecule and peptide portfolio, from preclinical through to the launch and the lifecycle of our marketed products.

The Responsibilities

• Ensuring day to day NMR analysis.
• Ensuring release and stability testing of API, standards, and clinical batches from Phase I to Phase III.
• Ensuring release testing of raw materials, starting materials, degradation products and intermediate of synthesis.
• Developing and validating fit-for-purpose of analytical methods according to aQbD principles (risk assessment, DoE, modelling) for APIs, Drug Products and In Process Control (IPC).
• Transferring analytical methods to CDMOs, QC and manufacturing units and participating in their lifecycle management.
• Providing high quality documentation of all technical work performed in the laboratory.
• Actively participating to project meetings as well as internal scientific meetings.
• Participating to the implementation of new state-of-the-art analytical methodologies and process improvements including bibliographic survey, technical scouting, and innovative methodological evaluation

Education Experience and Skills Required

• This position requires a bachelor/master’s degree with at least 2 years’ experience (e.g. Analytical Chemistry) in the pharmaceutical industry is required.
• Competence and autonomy in analytical development with NMR spectrometers.
• Basic knowledge of NMR is highly recommended.

• Key areas of expertise are the following:

• Experience in NMR for characterization, quantification, and structural identification of compounds.
• Experience in the development of analytical methods for small molecules and/or peptides.
• Understanding of regulatory, GMP and safety environments
• Experience using Bruker instruments and knowledge of Topspin/MestReNova is a plus.
• Knowledge of organic chemistry to facilitate the interpretation of spectroscopy results is a plus.
• Knowledge of the other characterization techniques (MS / IR / NIR / …)

• Key skills are the following:

• Able to work and respect the procedures in a regulated environment including good practices and HSE.
• Good interpersonal, verbal, and written communication skills in French and/or English.
• Team player, highly motivated with a strong client orientation.
• Demonstrated motivation for laboratory work and hands-on experience with analytical instruments.
• Ability to work in a matrix organization in different technical areas.
• Be able to find autonomously technical solutions and activate all appropriate internal /external experts to solve the issue.
• Be able to efficiently translate the data collected into knowledge that meets the needs of the project.
• Must be able to manage scientific tasks independently to meet deadlines within given challenging timelines. 

Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
 

• Location: Braine-l'Alleud
• Job #25276

Industrial Lead Analytical (ILA) Specialist

The scope of the position is global within the entire Transformational Programs & Infrastructure Department of our client’s company. The role is focused on supporting, from an operational and project execution standpoint, the Analytical Industrial Lead (ILA) of commercial products, from late phase development (for commercial readiness) to the end of the life cycle of products.

The Responsibilities

• Providing support and expertise to specific projects led by your team or stakeholders (e.g. implementation of a new regulations, coordination of stability studies to support a process change, support submission readiness for various geographies …).
• Implementing analytical life cycle plans or integrated analytical solutions through project management.
• Being responsible for one or more cross-products activities or business processes (in full or a part of it) within the remit of your department.
• Supporting ILAs for operational activities within the remit of the department.
• Connect with people to develop and maintain interfaces with operations (e.g. QC laboratories, CMO, CLO).
• Use your project management skills to implement decisions, plans, and solutions.
• Show-off your energy and dynamism to evolve in a complex matrix environment.
• Work in autonomy with a problem solving & pragmatic mindset.
• Work on several projects in parallel with agility and smooth communication to support members of the team.

Skills and Knowledge Requirements

• Master’s degree in analytical chemistry or biology
• Industrial experience in the analytical testing field of pharmaceutical products with some project management activities.
• Experience of contact with QCs Experience in Biological products is a plus.

• Proven project management skills including planning, monitoring, issue resolution, risk mitigation and reporting to team manager.
• Knowledge of QC laboratory work, LIMS knowledge is a plus.
• Support of operational activities such as sample shipment, request of QC data, support QC trouble shooting, support to deviations.
• Exposure to GMP, Regulatory Affairs and Quality applied to analytical.
• Fluent in English and French.
• Customer and results oriented.
• Ability to summarize challenges and issues to management.
• Knowledge of basic Microsoft tools (Teams, Excel, Powerpoint, …).
• Ability to review data and documentation with a scientific eye.
• Knowledge of pharmacopeias and Biological and Physchem methods is a plus.

Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]