Pharma MSAT Quality Lead Contracting – Walloon Brabant Your responsibilities?
Establish and build a network with the company key stakeholders in relation to Internal and External A/MSAT for Pharma Drug Substances and Drug Products.
Provide expert QA advice, support and management for technical operational QA and general QA matters associated with Internal & External Pharma A/MSAT, with the following focus: 2nd line troubleshooting (process and analytical)
Process improvement and life cycle management strategy within regulatory file boundaries (process and analytical)
Process industrialization and technical transfers (process and analytical) within commercial manufacturing facilities
Complex investigations and CAPA plans implementation (process and analytical)
Process validation oversight and continuous process verification (CPV)
Implement the established governance model and process for Quality oversight of Internal and External A/MSAT for Pharma 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 and represent the team in transversal projects and initiatives
Work closely with Global Quality teams and Business stakeholders in an effective and efficient way
Promote Best Quality Practices throughout the External & Clinical Supply Quality team and where possible business stakeholders.
As required, provide Operational QA support to other projects or vendors (e.g. Quality agreement preparation, follow up on audit observations and CAPA plan implementation, …) to support other team members or the wider team.
Upon request deputize for the Head of Pharma MSAT Quality and other Pharma MSAT Quality Leads in times of absenteeism (e.g., vacation, illness)
Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of business and professional career development
Your profile?
You hold a degree in a Master in a Scientific/Engineering domain
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. Operational experience, along with a manufacturing QA background and strong technical knowledge, is a key asset.
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.
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.
Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally, especially at senior management levels.
You speak fluently 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.
Support the pre-clinical CNS small molecule, antibody and gene therapy projects
Strengthen the capabilities in molecular biology tools to support pipeline projects.
Designing and implementing molecular biology tools, and bespoke read-outs.
Demonstrate expert knowledge in designing plasmids, shRNA, and CRISPR guides and register them in Benchling software.
Provide high-quality data and scientific support, keeping up to date with relevant scientific literature and proactively searching for new methodologies.
Your profile?
Master’s degree in the field of molecular biology, cell biology, or related. She/He will be skilled in using molecular biology tools, DNA/RNA extraction, RT-qPCR and cell culture related activities.
Expert knowledge in designing molecular biology tools: plasmid, shRNA and CRISPR guide design and registration in Benchling software
Expertise in RNA/DNA/miRNA extraction methods and QC (Tapestation)
Knowledge of PCR techniques: qPCR, RT-qPCR and ddPCR
Expert in cell line culture, expansion and transient transfection
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.
Distribution Quality Partner Contracting – Walloon Brabant
What are your responsibilities?
Operational Quality Support
Ensure cGMP/GDP and related regulatory requirements are successfully implemented and maintained within internal quality system.
Review and approve investigations, deviations, change controls, complaints, procedures or other process-related documents
Vendor Quality Management
Support GDP vendor management activities – periodic performance oversight, and resolution of quality issues, including writing and reviewing Quality Agreement.
Expert GDP Oversight
Act as an experienced SME for GDP matters within the team, supporting the team with interpretation of regulations.
Continuous Improvement
Identify opportunities to optimize distribution Quality processes and ways of working; propose and implement improvements to increase efficiency and inspection readiness of GDP activities.
Who are you?
A minimum of 5-8 years of experience in the pharmaceutical industry, previous experience in Quality in GDP
Deep understanding of EU GDP Guidelines (2013/C 343/01) and relevant cGMP concepts.
Strong knowledge of global distribution models (3PL, carriers, warehouses, temperature-controlled distribution).
Previous experience as Responsible Person is an asset
Ability to support daily Quality decisions (go/no-go for shipments, deviation triage, documentation review, write and review quality agreement).
Take ownership of topics and drive them to closure.
Analytical mind-set and very good organizational skills
Fluent in 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 will support the development and delivery of ADA immunogenicity assays and associated data sets in support of our biologics (NBE) and/or gene therapy pipeline.
Work within the bioanalytical teams to optimize experimental design, sample analysis, data interpretation and report generation.
Have an opportunity to support the delivery of other bioanalytical methods including, such as cell-based assays.
Your profile:
At least a BSc in a biological discipline with 1 year of hands-on experience in Bioanalysis.
Experience in developing and validating assays to assess immunogenicity.
Demonstrate in-depth technical understanding of ligand binding assays, particularly on platforms like MSD (Gyrolab, ELISA), dealing with complex ADA assays.
Experience with assessing and/or overcoming Drug, Target interference, presence of Pre-existing ADA, characterization of multi-domain specificity in immunogenicity assays.
Ensure adherence to quality standards while supporting the delivery of assays and critical data sets within project deadlines.
Ability to generate, analyze, interpret, and present critical data sets.
An ability to work in a matrix and communicate clearly.
Be agile and flexible in adapting to changing projects and organizational priorities, aligned with project deadlines and departmental needs.
Global Paper archivist Governance Lead & Process Data Owner
Contracting – Brabant Wallon
Your responsibilities: The company is creating a new global role to take full ownership of paper archiving governance across all sites and affiliates. Although a global paper archiving process already exists, its local implementation has not been consistently followed or monitored, leading to gaps, risks, and deviations. The objective is to harmonize, structure, and operationalize paper archiving practices globally, ensure inspection readiness, and reduce regulatory, data privacy, and operational risks. The role will also act as Process Data Owner, the paper archiving system already live in several countries and being extended further.
Interacting with global and local stakeholders to understand how paper archiving is implemented at site level.
Assessing gaps based on existing assessments and defining practical action plans.
Building and animating a community/network of archivists.
Supporting and governing the Doxis system (validation status, access, data structure, user support).
Reviewing and aligning retention schedules, procedures, and documentation.
Managing topics related to external archiving vendors (governance, access, quality agreements).
Preparing for inspections, managing deviations and CAPAs, and driving continuous improvement initiatives.
The role requires autonomy, initiative, and a “helicopter view” of global archiving activities.
Your profile:
Minimum 5 years of experience in records management or archiving within a regulated environment, with enough experience to work independently and proactively without close daily supervision.
Solid experience in paper archiving / records management.
Experience in a regulated environment (preferably pharmaceutical or healthcare).
Strong understanding of data integrity principles (ALCOA+).
Strong communication skills and ability to work within a global network.
Comfortable working in English and French.
Strong organizational and stakeholder management skills.
Soft skills (initiative, autonomy, communication, project mindset) will be a key evaluation criterion.
Nice to have:
Knowledge of GxP environments and differences between manufacturing, non-clinical, etc.
Experience with document management or archiving systems.
Your responsibilities: Part of the Internal Bio & GT manufacturing Systems Quality Team, you will:
Work closely with Clinical Manufacturing Teams to ensure that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
Ensure adequate QA support for environmental monitoring, qualification, validation (including cleaning) and maintenance of the equipment, classified rooms, HVAC used in development manufacturing areas
Drive the continuous QA improvement process. Ensure adequate documentation processes and systems are available and followed for development projects (SOPs / Protocols / Report review…)
Plan and manage compliance tours and on the floor spot-check of the GMP area, offering quality assurance support including but not limited to inspection.
Be partner with other departments to identify, mitigate and subsequently resolve compliance and quality issues (Investigations / deviations / out-of-specifications) that may affect development activities and products.
Support Change Control, Deviation, Events, Investigations,… and perform the QA evaluation
Ensure KPI (including extracts) are adequately maintained and Shared.
Ensure Issued Copy document are following the issued copy and reconciliation process
Your profile:
A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
QA/compliance experience in DS manufacturing, facility operation, laboratory compliance and quality systems is essential.
Good background knowledge of the pharmaceutical biologics industry and applicable technical aspects of the Business
Understands practical applications of GMP, compliance principles and theories including risk management
Fluency in French & English
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
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]
Your responsibilities: As a TST Portfolio Manager, you will use robust project/portfolio management and communication skills to set-up, structure & coordinate the CMC projects portfolio in line with the Assets & Patient Supply strategic plans for (a) given compound(s), managing the inter-connections across projects, ensure coordinated plannings & deliverables, the CMC resource allocation to projects, projects prioritization scenarios, budget, financial 10 years plan & tracking of actuals. This function implies close relationships within the technical teams, with Global Regulatory Affairs function within the Patient Evidence, Global Quality and Operational functions to ensure alignment with EU, US, JP & IM teams’ expectations. You are agile, structured, good team player, assertive, enthusiastic and with a positive mindset. As the TST Portfolio Manager, your main activities and roles & responsibilities will be the below:
Provide support and coaching to project managers for creating a master plan for their assigned project that includes timelines, required resources, the order of needed tasks, and the responsibilities of each project team member; the record and tracking of this information in the software applications
Work closely with the project managers to ensure that project milestones are met efficiently and within prescribed budget & resource constraints. Generate monthly reports on schedule adherence.
Consolidate all relevant CMC projects into a Portfolio per compound, ensuring appropriate links between projects, milestones and resources. Develop dashboard and KPI’s to drive efficiently the product portfolio inside the TST.
Identify any resource constraints proactively and drive the prioritization-making process in Patient Supply and CMC: prepare (and present) prioritization proposals to the Patient Supply LT or Asset LT for endorsement after TST agreement/discussion.
Coordinate budgeting effort to align Units, Operations, Functions and Practices to achieve consolidated product projects, budgets and monitoring.
Drive the increase of maturity on project management skills inside TST’s and identify areas of improvement for the CMC community.
Coordinate activities and knowledge gathering to ensure issues are addressed and escalated timely across the product portfolio stakeholders, with assertiveness and deep understanding of SME’s constraints on project/portfolio.
Your profile:
Minimum 5 years of project, program and/or portfolio management experience and in associated tools
Experience in enterprise planning/resource capability and systems. Knowledge of Planisware PPM tool is a strong asset
Solid understanding of the end-to-end CMC/Development (and associated disciplines) is a strong asset.
Languages: English & French
Robust knowledge of change management
A certification in PMP, PRINCE2, Agile, Lean or equivalent is a plus
Knowledge of the pharmaceutical environment; launch and life cycle management processes and the regulations applicable during development is an asset
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? This position will provide leadership and in-depth QA expertise in driving strategic and operational Quality Assurance activities associated with complex Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for the company Products.
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 to 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 (Vendor QA KPI tracker, QuickScore) 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 vendors.
When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the company Stability Program
Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed and 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 company Complaint System and provision of responses to the complainant are professionally coordinated and managed.
If needed work with the Vendor team and CMC Quality Lead to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) meeting. Coordinate vendor quality related investigations
Participate on ad-hoc basis to the company Product Change Control Committees for activities related to the vendors
Provide in-depth expert QA advice, support and management for technical operational QA and general QA strategic matters associated with the vendors
Work closely with Global 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
Developer and owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
Ensure all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
Ensure review of relevant RA dossier section related to the assigned vendors
Have the overview of the company audit and HA inspections related to the vendors. Track and follow-up on Audit observation and CAPA plan implementation at the vendor.
Be the QA stakeholder for Vendor Risk management.
Manage and control quality documents related to the vendors in the Controlled Documents System
Support on customer audits and Health Authority inspections at the vendors, as needed
Receipt, coordinate review and authorize product reworks and repackaging
Drive resolution for complex quality issues related to the vendors in scope including coaching other VQL’s on problem solving for complex issues. Be the point of contact for critical post-release vendor issues (supply chain, distribution, etc.). Challenge current practices for issue resolution and incorporate new perspectives into existing problems.
As required provide Operational QA support to other vendors
Act as substitute for other Vendor Quality Leads in times of absenteeism (e.g. vacation, illness)
Acts as a coach for VQL’s with less experience.
Work in accordance with internal HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
Acts as a Best Practice ambassador, leads best practices steams and uses knowledge of internal/external business environment to improve existing process.
Who are you?
Master’s degree in Life Sciences, Engineering, or a related field
Experience in Quality Assurance.
Experience in vendor management.
Experience with Quality Management Systems (QMS) in pharmaceutical manufacturing environments.
Knowledge of aseptic manufacturing processes.
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 work independently and handle complex / difficult situations. Output from actions will most likely impact activities across several departments.
Possess good auditing capabilities and skills.
Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.
Root cause and risk management/assessment 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.
The position can act as back-up for his direct colleagues after appropriate training
OPERATIONAL QA ROLE
Assure that intermediates and active pharmaceuticals products get produced and released in accordance with Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH)
Follow up of product related: change control, failure investigation, deviations, CAPA and action plans, qualification of dedicated equipment (protocols and reports)
Review of batch record from intermediates to drug substance
Batch disposition of chemical intermediates (DS manufacturing)
Review of master batch records and specifications
CONTINUOUS IMPROVEMENT
Support the Pharma Manufacturing (BPM) Management to develop and implement technically robust and compliant Process and Equipment Support Systems allowing to exploit, maintain, monitor and continuously improve their operations
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 at the site.
Using a Risk Based Approach, ensure that all BPM Systems, Processes, Operations and Activities are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Corporate Policies & Procedures hereby considering objectives, plans and projects
Promote quality and operational excellence and cultivate “Compliance Awareness”, “Continuous Improvement Attitude” & “Accountability Culture” across the BPM and related supporting services
Ensure general cGMP training of internal customers
Drive quality leadership and technical expertise on compliance strategy and interact with other functional areas to effectively communicate System & Process requirements
Ensure communication of compliance status and issues to appropriate levels of the organization
Ensure a relevant cGMP level regarding subcontractors used to support routine operations for BPM and related supporting services
Participate in the preparation for regulatory inspections and provide direct support to System Owners and main customers during inspections
Your profile:
Min 3 years experience in Quality Assurance in a regulated pharmaceutical environment or other life science or health related field
Experience with Chemical/ pharmaceutical production, development and /or regulatory requirements, including knowledge production best practices in pharmaceutical industry
Experience with Quality Management System
Ability to balance multiple priorities, provide leadership and prioritization, and work with minimal supervision
Excellent team player attitude with excellent interpersonal relationship and communication skills
Ability to plan and direct the actions of a group of professionals and Quality Assurance personnel in multidisciplinary investigations / meetings
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]
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]
