Your responsibilities: The Project Lead will contribute to the company main project “Batch Release digitalization and Electronic Batch record implementation including exception-based release” Project. through:
Defining projects objectives and road map
Guiding and supervising the activities and schedule of the projects to ensure each aspect is complete and accurate
Developing projects plans and presenting scope, solutions to manager
Coordinating, motivating, and leading a matrix team for the successful delivery of assigned projects involving cross-functional colleagues, and other stakeholders.
Managing and escalating projects risks and issues
Process mapping
Support Electronic Batch record roll out across sites with implementation of exception-based review.
Prepare the Selection and proll out exception-based release digital solution
Preparation of business case for one button digital release solution
Your profile:
Quality generalist, with a minimum of 5 years working in the pharmaceutical/biologics industry in a process improvement position or releasing/batch record review function.
Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
Must have a process improvement mindset, able to influence different stakeholders, find common ground and bring stakeholders closer together with aligned approach.
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
Holding a Qualified Person registration number is an asset.
Fluent in English & French
Experience with electronic batch record review is required
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]
QA Compliance Support Brabant Wallon – Contracting
Vos responsabilités ? Supporter les activités de production (Filling et Inspection Visuelle) en assurant :
Le suivi, la gestion et la rédaction des déviations, investigations et CAPA's associées
Le suivi des Change Control
Le suivi de projets internes de modification ou d'amélioration.
Supporter les team leader de production dans la gestion des incidents survenant durant les activités de remplissage et d'inspection visuelle pour délivrer un produit injectable de qualité tout en respectant les régies de sécurité et les objectifs du département en termes de cout /délai.
Supporter la production dans le cadre de projets pluridisciplinaires.
Participer activement à définir les stratégies de validation en collaboration avec les équipes validation et en respectant les requis internes
Revoir et approuver l’ensemble de la documentation liée à la validation, y compris les Periodic Review (si nécessaire)
Qualité :
Suivre, gérer et rédiger les déviations et investigations ainsi que les CAPA en collaboration directe avec les team leader, chefs d’équipes, opérateurs, QA et autres services concernés
Supporter les opérateurs, chefs d’équipes et team leaders de production dans la gestion des incidents survenant durant les activités de remplissage et d’inspection visuelle
Effectuer le suivi dans le système de gestion des déviations afin de respecter les délais de traitement des déviations et de libération des lots
Supporter les team leader dans la rédaction, le suivi et l’implémentation des change control relatifs aux activités de production
Respecter et promouvoir la culture qualité interne
S'assurer de l'alignement entre les équipes support et QA et les résoudre le cas échéant
Compliance :
Former et accompagner les équipes de production aux modifications/améliorations apportées aux process dans le cadre des investigations/CAPA/projets
Participer au développement et au maintien du système de qualité en vigueur au sein de la zone de production : supporter le département dans la rédaction des procédures, instructions et formulaires
Support au Département Compliance dans la gestion des change control compliance
Supporter le département à être “permanent inspection readiness”
Revoir la documentation liée à des CAPAs
Amélioration continue : Supporter les initiatives d’amélioration sur le terrain (5S, projets, smarter ways)
Votre profil?
Maitrise des cGMP’s et expérience dans un environnement de production pharmaceutique
Esprit d’analyse
Capacités rédactionnelles de rapports, investigations, procédures
Bonnes aptitudes de communication
Problem solving
Orienté(-e) terrain
Maitrise de l'anglais à l'écrit et à l'oral
Agir en tant que coach pour les autres membres de l'équipe et/ou expert dans certains domaines
Notre offre ? Nous vous offrons un contrat à durée indéterminée ainsi qu'un package salarial attractif. Vous profiterez également de l'opportunité de vous développer personnellement et professionnellement à travers des formations internes. Intéressé(e) ? N'attendez plus !
QA Scheduler Walloon Brabant – contracting Our partner is looking for a QA Scheduler to join its team. Our partner is well known for its pharmaceutical.
The QA Scheduler will design, own and optimize the QA scheduling to enable on-time product release, stable supply, and predictable performance coordinating priorities, risk and capacity. The QA Scheduler will support the designing phase of the role and required digital solutions strongly partnering with QA, Supply Chain and Production. In practice the QA Scheduler will support determining activities lead times, ability of the various Quality departments to abide by supply scheduling according to those defined lead times, review progress against schedule following on potential issues and delays, enabling prioritization and enhancing capacity planning.
Your responsibilities? Design and Deliver QA scheduling model:
Support creation and validation of the future-state QA scheduling model, including prioritization rules, decision logic, roles, and supporting governance
Support design and delivery of the QA digital solution, including MVP development, ensuring alignment to QA master data and end user requirements
Drive day-to-day execution of the design phase to deliver agreed milestones across solution design, governance, and change readiness
Prepare QA and adjacent teams for adoption through training, role clarity, and change management
Own and optimize the QA scheduling:
Translate release plans into a clear, executable QA schedule reflecting batch priority, urgency, and business risk
Maintain and optimize the QA schedule using agreed planning principles, ensuring focus on the most critical batches
Identify and manage short-term capacity constraints and delivery risks, driving timely resolution with leadership and cross-functional partners
Support long-term QA capacity planning by provide insights on demand trends
Enable and drive consistent use of QA digital solutions to improve visibility, prioritization, and decision-making
Identify and lead improvement initiatives to strengthen QA reliability, resilience, and speed
Communicate to stakeholders Deadlines for finalizing deviation investigations, change control action items and document updates in line with the release planning.
Follow up with stakeholder on timely closure of above items to ensure release within committed timelines
Communicate any issues with an impact on the release lead times to supply chain and agree with all involved stakeholders on new deadlines to resolve the issues.
Your profile?
Master’s degree in sciences Pharmacist / master’s in sciences / Bio Engineer pharmaceutical
Understanding of Global pharmaceutical industry including the interpretation and practical application of applicable regulations.
Must be able to act in most circumstances without direct supervision and handle complex/difficult situations.
Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally.
Must possess excellent coordination and team motivation skills.
Must have the ability to independently analyze data and information to draw conclusions and make effective decisions.
Must have ability to identify risks and propose corrective actions within areas of expertise. Also demonstrates initiative and the ability to help others solve problems in a creative and practical way.
Must be dynamic, assertive with strong organizational skills.
Previous experience in change management would be an advantage
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.
R&D and PV Compliance Lead Brabant Wallon – Contracting
Our partner is looking for an R&D and PV Compliance Lead to join its team. This international company is well known for its pharmaceuticals.
What are your responsibilities?
Manage GCP/GLP deviations and CAPA process according to RDPV Quality End-to-End Deviation Management process:
Identify quality issues that would classify as deviation events and facilitate the deviation investigation and root-cause analysis.
Enter and Manage Deviations and CAPA as per Source Quality (Veeva System) Deviation management processes.
Assess proposed CAPA of vendors and liaise with Process Owners, Subject matter experts (Quality or business) to ensure robust CAPAs are developed and negotiate the major observations with vendors or the company business partners.
Manage, track and facilitate the project management of timely review, evidence evaluation and closure of deviations and associate CAPA’s from deviations, audits and inspections.
Follow-up with CAPA owners to ensure timely review, approval and closure from deviations, audits and inspections.
Support development of Effectiveness Checks and ensure timely approval.
Escalate issues early within the company and ensure effective risk-based resolutions are in place.
Monitor the performance of (quality) systems and solutions and the quality of data to support oversight on critical to quality indicators and key decisions.
Conduct analytics and qualitative assessments to identify trends and deliver insights.
Develop periodic KPI and reporting to senior management (compliance dashboard).
Monitor the quality performance of internal processes, strategic vendors and partners.
Maximize the application of AI and machine learning (ML) in deviation management
Who are you?
Bachelor's Degree required; Master's Degree preferred in Life Sciences Related Field.
Preferable 5 years of experience working in the (bio)pharmaceutical industry preferred, with a minimum of 3 years in the research, clinical development or Pharmacovigilance domain.
Experience with managing non-compliance issues in Quality Management system as per deviation management processes. Familiarity with Veeva QMS system is an asset.
Proficient in GCP regulations and applicable regulatory framework. Expertise in another GxP area (GLP/GVP) is an asset.
Ability to translate regulatory and quality expectations into operations, based on knowledge of quality principles (e.g. risk-based decision making, data integrity)
Expertise in managing non-compliance, leading root-cause investigations, robust CAPA development and perform Effectiveness Checks in at least one of the GxPs (i.e. GcP). Expertise in another GxP area (GLP/GVP) is an asset.
Ability to drive collaboration and engagement across the stakeholder network, motivating others to achieve results and expertise working with service providers.
Skilled in influencing others within a global matrix organization and driving informed decision – making.
Ability to analyse data, perform trend analysis and lead meaningful discussions with business management for meeting compliance requirements.
Experience working with data analysis tools and notion of applying AI and Machine Learning in pharmaceutical industry.
Capable of prioritizing and focusing on critical issues using a risk-based approach
Manages quality and compliance issues with diligence, rigor, transparency and timeliness.
What can you expect? Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to training in technical matters and soft skills. We will be your career partner for each step along the way.
R&D and Pharmacovigilance Digital Quality lead 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.
What are your responsibilities?
GxP System & Technology 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.
External System Oversight (CRO / Vendor Systems)
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
Who are you?
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.
What can you expect? 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.
In Vitro Laboratory Scientist Brabant Wallon – Contracting Our partner is looking for an In Vitro Laboratory Scientist to join its team. This international company is well known for its pharmaceuticals. What are your responsibilities? As a Laboratory Scientist in the In Vitro Safety team, you will be responsible for designing, planning, and executing a wide range of hands-on laboratory experiments to support the drug discovery and safety assessment projects.
Execute in vitro and histology and wet laboratory-based activities from an experimental point of view
Design and plan experiments, organize and prepare samples, process experimental data, capture findings in reports and communicate with team members and project leads to optimally support project portfolio
Work independently and cross functionally across various teams to tackle scientific problems
Collaborate closely with senior scientists and pathologists to ensure accurate interpretation of in vitro and histological/immunohistochemical data
Ability to work independently, meet tight deadlines, and integrate novel technologies quickly
Present results and findings at internal project teams
Conduct in vitro experiments to identify potential liabilities in pre-clinical drug development
Develop, optimize, and validate IHC assays (e.g., colorimetric, fluorescent)
Design of experimental set-up, sample organization and preparation, data processing and analysis, reporting of the results
Ensure translation of strategy into hands-on lab work
Execute laboratory activities for the development and optimization of innovative methods and in vitro models, enabling biochemical and biological assays to elucidate molecular mechanisms of toxicity.
Ensure that activities are conducted in ethical and safe manner according to the company code of conduct
Guarantee proper experiment planning and execution, providing technical support when necessary
Who are you?
Master in biology, biochemistry, or immunology.
Expertise in mammalian cell culture (primary, iPSC), molecular biology (RNA, DNA, qPCR) and biochemical endpoints (Capillary electrophoresis-based immuno-assay, Western Blot, ELISA, MSD)
Previous experience with the technical steps in histology processing, including tissue trimming, embedding, sectioning, and staining (e.g., H&E, special stains).
Ability to think critically and demonstrated troubleshooting and problem-solving skills (identify problems, collect and analyze data, establish facts, and draw valid conclusions)
Well organized, flexible, meticulous and rigorous with good time management
Good skills in scientific writing and competence in creating reports
Ability to work independently in experimental design, execution, data analysis, data interpretation and communication
What can you expect? 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.
Vendor Quality Lead – QP Contracting – Walloon Brabant
Our partner is currently looking for a VendorQuality Lead to join its team. This international company is well-known for its pharmaceuticals.
What are your responsibilities? In this position, you will support the Qualified Person (QP) in relation to all batch release activity for Global products produced by third parties, primarily performing QA review of batch documents, issue of batch certificates, and transactional release activities.
Vendor Quality Lead (VQL) related accountabilities:
Be the central QA point of contact for the organization for investigations/deviations/ out of-specifications/ audit observations associated with the assigned vendors.
Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders allow assessment.
Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools and track the vendor’s performance.
Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product CMC Quality Leads and the vendors.
When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the internal Stability Program
Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensure that this review is documented and made available in the internal Controlled Documents System.
Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings.
Quality Complaints: Be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the Complaint System and provision of responses to the complainant are professionally coordinated and managed.
Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors.
Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way.
Cover the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors.
Owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors.
Qualified Person related accountabilities:
Support the QP in relation to all batch release activity, primarily performing QA review of batch documents.
Issue batch certificates for product release and distribution
Perform in SAP the transactional product release and maintenance of batch release register
Liaise with Vendor Team(s) and CMO’s where applicable on resolution of issues relating to document errors to support release.
Act as QA contact (in conjunction with site QP) and deputize on behalf of QP where appropriate for product related quality issues and associated communications.
Act as a contact with other departments and Affiliates to support the drug product /Finished goods release process and supply of post release documents.
Maintain and report Metrics relating to batch release activities.
Support Global Regulatory Affairs and CMC Quality Leads for submission document requests
Coordinate legalization/notarization of documents as needed
Who are you?
Eligibility as a Qualified Person in EU
Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations.
Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
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 be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations.
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.
Quality System Contractor Brabant Wallon – Contracting
What are your responsibilities?
Support and prepare for regulatory inspections and audits.
Lead or assist in Quality Council and Risk Management Committee activities.
Develop and maintain internal audit and self-inspection programs.
Structure and align local documentation with global standards.
Implement and lead local Quality System Reviews.
Promote quality culture and regulatory awareness among staff.
Act as a mentor/coach for quality and regulatory requirements.
Benchmark industry trends and support local/global quality initiatives.
Who are you?
Minimum 8–10 years of experience required in pharmaceutical quality systems.
Pharmaceutical industry experience.
Demonstrated experience in quality systems and compliance.
Experience in audits and inspections.
Ability to work autonomously and proactively.
Fluent in French and English.
Strong interpersonal skills; not afraid to reach out and follow up with colleagues.
Nice to have:
Experience with biological drug substance (business and/or quality).
Agility to handle unpredictable changes and a stressful environment.
Experience collaborating and influencing across departments.
Additional certifications in quality or regulatory affairs.
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 invite you to apply!
Prepare samples, process data, write reports, and present results.
Collaborate with the team to share instruments and knowledge.
Your profile:
Experience in mass spectrometry (high-resolution LCMS).
Skills in analytical method development.
Autonomous work style and ability to manage own schedule.
Good English proficiency (for meetings and international interactions).
Understanding and respect for GMP rules.
Ability to interpret complex spectra, especially for polymers and biomolecules.
Nice to Have:
Experience with polymers and large molecules.
Knowledge of biomolecules (proteins, antibodies).
Experience in a GMP environment.
Willingness to collaborate and support teammates.
Familiarity with various mass spectrometry instruments.
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]
Scientist, Injectable Drug Product Process Development
Walloon Brabant – Contracting
Major Responsibilities
Design and execution of lab studies in relation to drug product development activities, capture and analyze data and author related documentation (write-ups, protocols, reports (e.g. filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc.) ;
Capture and analyze critical manufacturing process data for process understanding and process characterization ;
Perform process risk assessments ;
Design DP processes for sterile injectable drug products in liquid or lyophilized powder form, in vials, pre-filled syringes or as combination products) ;
Define the investigational medicine product preparation process in clinical trials ;
Provide support to ensure timely manufacture of stability and clinical DP batches ;
Provide support to process performance qualification/validation Ensure products are manufactured in accordance with the client's quality system, cGMP and latest regulatory requirements ;
Provide support in the completion of the relevant sections of the CMC regulatory submissions and regulatory briefing documents and response to questions from authorities ;
Provide support in investigations of deviations and complaints related to DP quality ;
Support knowledge transfer from late phase development to commercial for validated DP processes ;
Contribute to develop the ways of working in the department.
Profile
Bachelor's Degree ;
2–3 years of experience in manufacturing or production support ;
Knowledge of fill & finish processes (even indirect) ;
Ability to work independently after a few months ;
Scientific critical thinking ;
Clear and transparent communication ;
Motivation and energy ;
Fluent English (documents, meetings, interactions) ;
Scientist grade.
Nice to Have:
Experience with syringes or injectable liquids ;
Experience working with CMOs ;
Understanding of fill & finish steps and their impact on the product ;
Ability to translate needs into lab language/protocols ;
Experience writing scientific reports.
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]
