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General Management

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Head of CMC - Bio-Pharma/Biotech - Liège

ASIT Biotech is a Belgian clinical-stage biotech company focused on the development of breakthrough immunotherapy products for the treatment of allergies.

Thanks to its innovative technology platform, ASIT Biotech currently holds a leading and unique position on the market. This innovation results in a short treatment, expected to improve patient compliance and quality of life. ASIT Biotech’s product pipeline targets to significantly expand the current immunotherapy market. For more information about the company, please visit www.asitbiotech.com.

With a headcount of 25 staff members, ASIT Biotech is located in Liège, Belgium. In order to support its high-potential developments, we are looking for a (m/f):

Head of CMC

Responsibilities :

As Head of CMC, you are responsible for all CMC-related technical operations activities, including overall management of process and product development, selection and oversight of the pharmaceutical supply chain, technology transfer, manufacturing and supply of clinical trial material. You ensure the Quality and RA compliance of CMC-related activities with the corporate policies.

You report directly to the CEO and are part of the Executive management.

Your main responsibilities include:

  • Lead the overall management of product and process development.
  • Manage all drug substance and drug product activities from technology transfer to clinical supplies for clinical studies.
  • Identify, select and manage CMOs for process optimization, cGMP manufacture, supply, testing, release and distribution of Drug Substance (API) and Drug Product (DP).
  • Manage the non-GMP productions and associated analytical development activities.
  • Deliver robust, scalable and cost-effective manufacturing routes.
  • Implement appropriate analytical methods and protocols in coordination with QA.
  • Ensure the compliance of all CMO with relevant regulatory standards.
  • Define and execute plans for API and DP validation and registration, in coordination with QA and RA.
Profile :
  • PhD in Life Science with at least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment.
  • Relevant expertise in lab techniques focused on protein expression, isolation and analysis.
  • Strong experience in managing CMOs for the manufacture of cGMP APIs and DP.
  • Experienced in cGMP manufacturing and IND, CTA and NDA regulatory filings.
  • Thorough knowledge of relevant FDA and EMEA regulations.
  • Experience with implementing technical, strategic and operational plans.
  • Excellent communication and organizational skills.
  • Ability to identify and resolve critical issues.
  • Fluency in French and English.
Offer :
  • A challenging leading position within a stimulating and dynamic work environment.
  • A variety of interesting contacts with international exposure.
  • The opportunity to have direct impact on the results of a high-potential biotech company.
  • An attractive compensation package in line with the position responsibilities and your experience.

Other career opportunities

45 results

Medical Officer - Biotech, Biotechnology - Mont-Saint-Guibert

NOVADIP BIOSCIENCES (www.NOVADIP.com) is an innovative biotech company expert in the development of novel regenerative medicines. This human-sized structure is a leader in new generation therapies for hard & soft tissue reconstruction from autologous adipose stem cells.

NOVADIP BIOSCIENCES shows the ambition to grow to a worldwide class, with a successful closing of a 28M€ fund raising. Its main objective for the coming years is to develop its portfolio of products and to perform clinical validation and process industrialization of its main compounds.

NOVADIP BIOSCIENCES is a French/English-speaking work environment based in Mont-Saint-Guibert (close to University of Louvain-la-Neuve and Brussels area), Belgium, Europe.

In order to support our clinical development, we are actively looking for a (m/f):

Medical Officer

Responsibilities:

As a Medical Officer, you are part of the Medical Department consisting of the Chief Medical Officer, a Compliance Manager, 2 Clinical Project Managers, 2 Clinical Research Associates and a Clinical Research Assistant. You closely collaborate with them.

Your main responsibilities are as follows:

  • Design, contribute and write new study protocols and documentation related to clinical trials (IMPD/IND, investigator brochure, sponsor master files, patient informed consent, CRF, monitoring plan, safety plan /DSMB…) and contribute to the design of clinical development plans.
  • Develop and maintain a network of medical experts in the field and work in close collaboration with internal departments (i.e. R&D, Regulatory Affairs, Manufacturing, logistics…).
  • Identify, screen, select, initiate clinical sites, CROs, and other sub-contractors in the future trials in collaboration with clinical team.
  • Set up pharmacovigilance program (standalone or in collaboration with CRO).
  • Manage the interactions with ethics committees.
  • Monitor trials from a medical point of view, together with internal staff and clinical sites personnel.
  • Review incoming clinical data, and write medical reports or any other scientific files in collaboration with the Chief Medical Officer.
  • Facilitate communication flow between the clinical sites, CROs and Novadip.
  • Share your knowledge with the teams in order to overcome scientific, operational, regulatory, marketing, financial and strategic challenges within the company.
  • Active participation in training/coaching of operational teams involved in clinical trials (internal and external).
  • Report to the Chief Medical Officer.
Profile:
  • MD, PhD in Medical Sciences or Master in sciences or related field.
  • Min. 5 years of experience within either a CRO or a Pharma/Biotech/Medtech company. Experience in cell therapy is a great asset.
  • In depth understanding of clinical development plans, clinical trials, and superior knowledge of IHC-GCP.
  • Interest in basic sciences and translation of medical science in new clinical trials protocols.
  • Good communication skills with both clinical and non-clinical contacts.
  • Excellent attention to details and established organizational skills.
  • Demonstration of flexibility, professionalism, good interpersonal skills and managerial skills.
  • Fluency in written and spoken English is required. Good level of Dutch or French is desired.
  • Willingness and ability to be based in Belgium and to travel nationally and internationally.
  • To be in the possession of a full driving license.
Offer:

A diversified full-time permanent position within a high-potential innovative biotech company.

  • To work in a human-sized, dynamic, respectful and professional environment.
  • The opportunity to take part in a challenging scientific and business growth.
  • Varied contacts inside the company and with the biotech/pharma sector.
  • An attractive salary package in line with the position responsibilities and your experience.

Responsable Administratif et Financier - Belgian Brewery - Péruwelz

La Brasserie Caulier est une entreprise familiale de la région de Tournai, située à Péruwelz. La brasserie produit ses propres bières depuis près de 20 ans et jouit d’une excellente réputation dans le secteur.

L’équipe actuelle, composée de 17 passionnés, brasse des bières 100% naturelles, appliquant des méthodes de fabrication artisanales. La brasserie connaît une croissance importante depuis quelques années et vient d’entamer un vaste plan d’investissement qui lui permettra de doubler sa capacité de production.

Afin de soutenir la croissance de la Brasserie Caulier, nous sommes à la recherche d’un (h/f) :

Responsable Administratif et Financier

Responsabilités :

En tant que Responsable Administratif et Financier, vous faites partie de l’équipe de direction et êtes responsable des composantes administratives, financières et RH de la brasserie. Par votre intervention, vous facilitez la gestion opérationnelle de l’entreprise et la prise de décisions stratégiques.

Vous principales responsabilités sont les suivantes :

  • Mettre au point les budgets annuels avec le directeur général et veiller à leurs suivis.
  • Définir et mettre en place un système de contrôle de gestion efficace, notamment en améliorant l’implémentation et l’utilisation de Microsoft NAVISION.
  • Prendre en charge l’ensemble des démarches administratives, comptables et juridiques liées à la gestion de la brasserie.
  • Implémenter une gestion efficace des RH pour anticiper les besoins de l’organisation (recrutement, formations, politique salariale, établissement fiche de paie, etc.).
Profil :
  • Vous êtes titulaire d’un Master en économie, finance ou gestion.
  • Vous avez entre 2 et 8 années d’expérience, dont une première expérience en contrôle de gestion. Une expérience dans l’implémentation d’un ERP est un avantage.
  • Vous démontrez une passion pour la gestion d’entreprise et le monde brassicole.
  • Vous disposez de très grandes compétences analytiques et organisationnelles.
  • Vous démontrez d’excellentes aptitudes communicationnelles et relationnelles.
  • Vous travaillez aisément en équipe, et vous êtes force de persuasion.
  • Vous êtes reconnu(e) pour votre rigueur, votre autonomie, votre sens de la diplomatie et votre capacité à travailler par projet.
  • Vous êtes pragmatique, et orienté(e) résultats et solutions.
Offre :
  • Une fonction diversifiée comprenant de nombreuses responsabilités.
  • Des possibilités de formations, de développement et d’évolution de carrière.
  • L’opportunité de rejoindre une entreprise familiale et conviviale, et de contribuer à sa forte croissance.
  • Un contrat à temps plein et à durée indéterminée, assorti d’un package salarial adapté à votre profil, à votre niveau d’expérience et au contexte.

Field Application Engineer - Green-Tech - Liège

SmartNodes is a Belgian innovative green-tech start-up active in the smart cities’ sustainable development.

Based in Liège, SmartNodes develops smart street lighting solutions based on high-tech controllers to power street lighting only in presence of road users.  The measurement of traffic density and user speeds is used for road mobility and safety applications.  By integrating environmental sensors, parking sensors, etc., SmartNodes’ public lighting network is becoming the driving force behind Smart City networks.  Please visit www.smartnodes.be.

SmartNodes’ customers are cities, regions and distribution network companies, worldwide.
In order to develop its business, we are actively looking for a (m/f):

Field Application Engineer

Responsibilities:

As a Field Application Engineer, you are the technical contact point for customers in both pre- and after-sales operations. You maintain close contact with customers in order to fixe their technical issues and to identify technical upgrade and commercial opportunities.

Your main responsibilities are:

  • You propose, with the support of the R&D organisation, the most suitable solution based on the customers’ specifications and expectations.
  • You support customers with technical trainings.
  • You closely follow-up and support customers during the installation phase and during evaluation periods on site.
  • You participate to international trade shows, exhibitions and events with technical demos and papers.
  • You write customer training and customer projects related notes.
  • You report work evolution on a regular basis.
Profile:
  • Bachelor or Master degree in engineering, electronics or IT, or equivalent through experience.
  • 0 to 3 years experience in the industry. Junior profiles applications are welcome.
  • Good communication skills and the will to fix technical issues with customers.
  • Self-motivated, hands on, results, rigorous and flexible.
  • Prone to travel around 50% of your work time.
  • Perfect command in spoken and written English and Dutch.
  • Knowledge in spoken French and German is an asset.
Offer:
  • A diversified technical customer support position in a fast growing start-up.
  • The opportunity to enter a sustainable development and green tech company.
  • Varied contacts with professionals on an international scale.
  • Significant learning and evolution opportunities.
  • An attractive salary package coherent with your experience.

Ingénieur Commercial - Energie - Paris

Dunkerque LNG est en charge de l’exploitation et de la commercialisation du terminal méthanier de Dunkerque, deuxième plus grand terminal méthanier d’Europe continentale.

Fort d’un chiffre d’affaire annuel de 190€ millions, Dunkerque LNG est un atout majeur dans le développement de la stratégie d’approvisionnement en gaz du groupe EDF en raison de son raccordement unique à deux marchés de consommation : la France et la Belgique.

La société est composée d’une vingtaine de collaborateurs répartis sur les sites de Dunkerque et de Paris La Défense.

Afin de renforcer l’équipe commerciale de Dunkerque LNG à Paris, nous sommes activement à la recherche d’un (h/f) :

Ingénieur Commercial

Responsabilités :

En tant qu’Ingénieur Commercial, vous participez activement au développement du terminal tant d’un point de vue commercial qu’opérationnel. Rapportant au Directeur Commercial, vous êtes responsable de la relation commerciale avec les clients et les différents partenaires de Dunkerque LNG.

Vos principales responsabilités sont les suivantes :

  • Entretenir et développer la relation commerciale avec les clients de Dunkerque LNG, EDF et Total.
  • Veiller au respect des contrats de réservation de capacité et de leur mise en œuvre opérationnelle.
  • Supporter la Direction Commerciale dans le pilotage de la relation contractuelle et/ou opérationnelle des prestataires : suivi du contrat de service, lancement et réception de nouveaux développements, etc.
  • Prospecter de nouveaux clients, notamment en participant à différents forums et salons industriels.
  • Planifier et gérer l’activité du terminal : bateaux, émission, stock, etc.
  • Rapporter de manière régulière la performance commerciale et opérationnelle du terminal.
  • Participer aux astreintes de soutien à raison d’une semaine sur quatre.
Profil :
  • Vous êtes titulaire d’un Bac+5 de type école de commerce, d’ingénieur ou universitaire.
  • Vous êtes fraichement diplômé(e) ou possédez une première expérience dans le secteur gazier.
  • Vous êtes orienté(e) clientèle, résultats et solutions, et doté(e) d’un très bon relationnel.
  • Vous êtes flexible, autonome, organisé(e), analytique et rigoureux(se).
  • Vous communiquez aisément en Français et en Anglais.
  • Vous êtes basé(e) à Paris La Défense et disposé(e) à vous déplacer de manière régulière à Dunkerque et ponctuellement à travers le monde.
Offre :
  • Une fonction stimulante au sein d’un environnement diversifié.
  • L’opportunité de rejoindre un acteur majeur dans l’industrie du gaz en Europe.
  • Des challenges et des contacts variés au sein et en dehors de l’organisation.
  • Des opportunités de développement et de formations.
  • Un salaire attractif reprenant des avantages extra-légaux avantageux.

Head of Regulatory Affairs - Biotechnology - Gosselies

Our client is a clinical stage biotech company leading the development of new therapies for rare diseases affecting the central nervous system. The company is backed by strong international investors.

The company’s leading program is currently in an ongoing phase II/III clinical trial in EU and US, with results expected in 2020. In the upcoming months, our client is planning to launch a clinical trial for a second orphan indication. For more information about the company, please contact us via recruitment@pahrtners.be

Founded in Spain, the company is opening a subsidiary in Gosselies (Belgium). In order to strengthen the team in Belgium, we are currently looking for a (m/f):

Head of Regulatory Affairs

Responsibilities:

As a Head of Regulatory Affairs, you serve as a key and active member of the director leadership team, making sure regulatory objectives are met. You lead the organization on regulatory affairs, coordinate with regulatory advisors and mentors and provide training and interpretation of global regulatory requirements to all company personnel.

Your main responsibilities are:

  • Provide regulatory strategy and lead all regulatory interactions.
  • Author or co-author all regulatory documents (background documents, orphan designations, other) with appropriate support as needed.
  • Serve as liaison with EMA/CHMP.
  • Coordinate all FDA interactions with the support of US personnel (contractor or internal).
Profile:
  • Master’s degree in life sciences or equivalent through experience.
  • 10 years of experience in regulatory affairs within pharma/biotech industry.
  • Experience with both FDA & EMA.
  • Experience on processes such as ODD, fast track designation, PRIME, breakthrough and/or pediatric review priority voucher.
  • Experience in small molecules and orphan drugs is an asset.
  • Flexible, good time management, team-working skills, stress resistant, ability to work proactively and independently.
  • Well-developed communication skills, problem solving skills, creative thinking.
  • Fluent in English. A good command of French and/or Catalan is an asset.
  • Prepared to travel to Spanish site regularly.
Offer:
  • An interesting position within a high-potential clinical stage biotech company.
  • The opportunity to work in a human-sized and multicultural team environment.
  • A variety of interesting contacts with international exposure.
  • An attractive salary package in line with the position responsibilities and your experience.

 

Hardware Engineer - Green-Tech - Liège

SmartNodes is a Belgian innovative green-tech start-up active in the smart cities’ sustainable development.

Based in Liège, SmartNodes develops smart street lighting solutions based on high-tech controllers to power street lighting only in presence of road users.  The measurement of traffic density and user speeds is used for road mobility and safety applications.  By integrating environmental sensors, parking sensors, etc., SmartNodes’ public lighting network is becoming the driving force behind Smart City networks.  Please visit www.smartnodes.be.

SmartNodes’ customers are cities, regions and distribution network companies, worldwide.
In order to develop its business, we are actively looking for an (m/f):

Hardware Engineer

Responsibilities:

Reporting to the R&D Manager, you are developing hardware devices with sensor capabilities. You maintain close contact with Marketing in order to identify technical upgrade of current solutions and commercial opportunities.

Your main responsibilities are:

  • You propose, with the support of the R&D Manager, the roadmap of hardware devices with sensor capabilities.
  • You develop, maintain and upgrade SmartNodes sensors solutions.
  • You develop, maintain and upgrade hardware applications and/or you customize existing standard hardware to the most suitable solution based on the customers’ specifications and expectations.
  • You participate to demonstrations and hardware development projects.
  • Your report work evolution on a regular basis.
Profile:
  • Master degree in engineering, electronic or IT, or equivalent through experience.
  • 0 to 3 years experience in the industry. Junior profiles applications are welcome.
  • Good knowledge of sensors hardware concepts.
  • Good understanding of the algorithms used on the sensors.
  • Solutions, quality, innovation and results oriented, with good communication skills.
  • Self-motivated, team player, hands on, autonomous, rigorous and flexible.
  • Very good command in spoken and written English.
  • Good working knowledge in spoken French and Dutch.
Offer:
  • A diversified and challenging technical position within a dynamic team in a fast growing start-up.
  • The opportunity to enter a sustainable development and green tech company.
  • Varied contacts with professionals on an international scale.
  • Significant learning and evolution opportunities.
  • An attractive salary package coherent with your experience.

Senior product engineer - Medical Device - Awans

Miracor Medical is a class IIb/III medical device company specialized in improving clinical outcome of patients with impaired cardiac function, active in interventional cardiology. The company has developed a high potential proprietary technology that consists of hardware, software and catheter(s).

The technology is in advanced clinical stages, with various potential therapeutic applications (among others acute infarct and heart failure). More than 190 patients have been treated with the recent version of the technology. The company aims at getting CE Mark and approval from FDA to run a pivotal study in the next 2 years.

Miracor Medical’s offices are based in Awans, Belgium. The company is now looking for talented and enthusiastic talents to expand its international team. For additional information about the company and its technology, please visit www.miracormedical.com. 

Miracor Medical offers a culturally diverse English speaking working environment in the heart of Europe, Belgium, a few hours away from Europe’s capital cities.

To support the development of the company, we are looking for a (m/f):

Senior product engineer

Responsibilities:
  • You initiate and manage related projects.
  • You guide/manage risk management activities.
  • You create/review technical documentation and processes (as part of DHF, DMR, QMS).
  • You create verification and validation plans and coordinate their execution; apply statistical techniques in order to define samples sizes.
  • You organize and execute subjective evaluations (product reviews) to ensure all (product) requirements are met.
  • You review manufacturing documentation such as procedures/processes, BOMS and drawings.
  • You transfer and oversight of parts of manufacturing processes.
Profile:
  • Master’s degree in Engineering, Informational Systems or Computer Science.
  • 10+ years’ experience working in development of Class III (minimum IIb) medical devices (or other relevant regulated industry).
  • Ideally experience with hardware/software and catheters.
  • Experience in creating Risk Management plan, (Software) Hazard Analysis, DFMEA, PFMEA, Risk Management reporting.
  • Deep understanding of MDD (MDR), FDA 21 CFR 820, ISO13485 and ISO14971 standards
  • In-depth knowledge of the concepts of: design control, engineering change control, statistical techniques, verification and validation methods/protocols, design history files (DHF) and device history and master records (DHR/DMR).
  • Extensive understanding of statistical analysis, measurement and calibration systems, quality testing, sampling and inspection, process control, SOPs, etc.; Six Sigma certificate.
  • Excellent organisational and communication (oral and written) skills.
  • Ability to work on teams as well as individually.
  • Fluent in English (oral and written).
Offer:
  • A challenging and diversified position within a high-potential innovative medical device company.
  • To work in a human size, dynamic, respectful and professional environment.
  • International exposure, with learning and development opportunities.
  • An attractive compensation package in line with the position responsibilities and your experience.

Research Associate – Target expression - Biotechnology - Brussels

Confo Therapeutics, a spin-off of VIB and VUB, is a drug discovery company built around a disruptive technology which enables it to address ‘undruggable’ GPCRs. The company is building a portfolio of transformative medicines in various disease areas.

Confo Therapeutics is currently located on the Etterbeek campus of the Vrije Universiteit Brussel and on the Technology Park in Zwijnaarde/Ghent. More information about Confo’s technology and strategy can be found on www.confotherapeutics.com.

For the expansion of the target discovery team in Brussels, we are looking for a (m/f):

Research Associate – Target expression

Responsibilities:
  • You will help to implement a state of the art cell culture lab and build an efficient cell culturing engine for different eukaryotic hosts.
  • You will overexpress GPCRs in different eukaryotic expression hosts and assess recombinant receptor expression (transient and stable cell lines).
  • You support the Confobody discovery teams to assess conformation sensitivity of antibodies in cell based assays.
  • You manage Confo Therapeutics’ cell line culture capacity and inventory aligned with the Data Management System.
  • You communicate experimental progress to the project teams.
Profile:
  • Bachelor in life sciences with at least one year experience in eukaryotic cell culturing in an industrial setting.
  • Proficient in eukaryotic cell transfection techniques and methods to assess heterologous protein expression such as flow cytometry and radioligand assays.
  • Experienced operator of flow cytometer and capable to analyse flow cytometry data is an asset.
  • Scientific integrity, solid analytical and problem solving skills.
  • Working accurately and self-motivating.
  • Enthusiastic team player in a small company setting.
  • Excellent communication skills in English.
Offer:
  • A competitive compensation package with extensive benefits.
  • An entrepreneurial and stimulating working environment in a growing and ambitious biotech company.
  • Excellent career development opportunity, with exposure to all aspects of R&D in the company.

PLC and safety instrumented systems engineer - Oil industry - Antwerpen

As a global energy leader, Total is the fourth oil and gas company worldwide and a major player in low-carbon energies.

The Group operates in 130 countries and employs 98,000 people. Total explores for, produces, transforms, markets and distributes energy in a variety of forms, to serve the end customer.

Total’s strategy is to become the responsible energy major, providing affordable, reliable and clean energy to as many people as possible.

In order to strengthen the team in Antwerpen, we are actively looking for a (m/f) :

PLC and safety instrumented systems engineer

Responibilities :
  • Develop and realize soft- and hardware modifications on safety PLCs, non-safety PLCs, machine monitoring systems, industrial networks and SIS.
  • Follow up and support the exploitation and maintenance works on PLCs, monitoring systems and industrial networks, including analysis of failures.
  • Provide technical and general support to other departments on PLC systems, monitoring systems and SIS competence.
  • Update periodically the long term capital investment plan, according life cycle of systems, to prevent obsoleteness.
  • Develop projects up to +/- 500 k€ , including coordination of engineering phases, procurement of materials and services, coordination of project works, start-up, commissioning and training.
  • Participate in large multidisciplinary projects, supporting development and realization of PLC aspects.
  • Manage SIS technical data, including validation of safety test instructions and calculated SIL levels.
  • Follow up support and spare parts contracts with third parties.
  • Update and develop technical procedures.
  • Take an active role in the international networks of Total.
Profile:
  • You are an engineer, or equivalent based on experience.
  • You have expertise in:
    • Classic instrumentation in a petrochemical environment.
    • Development and troubleshouting of various PLC and monitoring systems (preferentially: Honeywell FSC / Safety Manager, Hima Himatrix / Hiquad, Schneider Modicon, Bently Nevada).
    • Development and calculation of SIS (IEC61508, IEC61511).
  • You are fluent in both Dutch and English.
  • You demonstrate a high level of self-discipline, and have a high standard on quality and safety.
  • You have a pragmatic and analytical approach.
  • You are well organized and stress resilient.
  • You are a good communicator and a team player, and can also work independently in a complex and fast changing environment.
Offer:
  • The opportunity to join an innovative and globally renowned industrial company.
  • Development opportunities and a structured evolution plan.
  • Professional and stimulating challenges.
  • A competitive salary package, in line with your experience.

Head of RA - Bio-Pharma/Biotech - Liège

ASIT Biotech is a Belgian clinical-stage biotech company focused on the development of breakthrough immunotherapy products for the treatment of allergies.

Thanks to its innovative technology platform, ASIT Biotech currently holds a leading and unique position on the market. This innovation results in a short treatment, expected to improve patient compliance and quality of life. ASIT Biotech’s product pipeline targets to significantly expand the current immunotherapy market. For more information about the company, please vist www.asitbiotech.com.

With a headcount of 25 staff members, ASIT Biotech is located in Liège, Belgium. In order to support its high-potential developments, we are looking for a (m/f):

Head of RA

Responsibilities:

As a Head of RA, you lead and drive the execution of ASIT global regulatory and quality assurance strategy. Reporting to the CEO, you are responsible for regulatory affairs, quality assurance, and compliance activities across the company. You define and implement the quality and regulatory policies in line with applicable directives, guidelines and legal requirements.

Your main responsibilities are as follows:

  • Develop, propose and implement the company regulatory & quality strategy.
  • Manage regulatory documents submissions for clinical studies, and product approvals.
  • Implement an efficient quality system and a continuous improvement culture within the company.
  • Interact with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and follow-up of
submissions.
  • Support and advise project teams on regulatory and quality issues.
  • Provide technical review of data and reports for regulatory submissions.
  • Draft product labelling, instruction leaflets and packaging.
  • Participate in internal/external audits, inspections and provide post-inspection
follow-up.
  • Write and update SOP, work instructions, and policies.
Profile:
  • Master or PhD in life sciences or equivalent through experience.
  • 10 years experience in a RA and/or a QA management position in the Biotech/Pharma sector.
  • Track record in developing quality systems from EU/US clinical developments to product approval.
  • Thorough knowledge of ICH guidelines, GxP and related regulatory guidances.
  • Proven track record of building strong relationships with internal and external stakeholders.
  • Ability to maintain multiple projects and meet timelines, including change management skills.
  • Client-centered and solution-oriented, with hands-on and pragmatic mindset.
  • Excellent leadership, communication and interpersonal skills.
  • Familiar with MS Office solutions.
  • Fluency in English.
Offer:
  • A challenging leading position within a stimulating and dynamic work environment.
  • A variety of interesting contacts with international exposure.
  • The opportunity to have direct impact on the results of a high-potential biotech company.
  • An attractive compensation package in line with the position responsibilities and your experience.