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Find your job with Axepta SA

Senior Product Director Biologics

Axepta SA
Switzerland, Vaud, Lausanne - Axepta SA
Pharmaceutical
Project / Program Management

My client is an innovating, dynamic and growing international pharmaceutical and healthcare company currently expanding their product development team in Switzerland, Lausanne. Due to this growth my client is looking for a Senior Product Operation Director to oversee a portfolio of projects as the primary liaison between market needs, strategic plans, R&D development efforts and global Operations network to bring product to market.  You will be empowered to successfully launch of their leading biologic product and manage the product throughout its full life cycle, leading a high performing team, and ensuring continued product availability at optimal quality, on time and in cost.                         Responsibilities   - Lead the Product Operations Team, applying broad knowledge of supply chain, manufacturing technology, regulatory requirements, quality standards, financial aspects, and business processes - in a biotech environment - to drive maximum product value - Provide leadership for launch, geographic roll-out, new indications and end-to-end life cycle management projects - Construct program plans and reviews/challenges key activities/assumptions for all related projects, including critical path analysis of the program plan on a continuing basis in accordance with project management methodology and applicable standards - Analyze and integrate data from across functional areas to provide strategic guidance to the team in developing and executing projects and applies this to update strategies, priorities and projects - Is the primary source of communication regarding the project within the Operations organization - Work with Product Operations Team to ensure that strategies, recommendations and emerging issues are appropriately communicated to key stakeholders, and as needed, work to achieve cross-functional alignment - Develop and maintain a high performing team, building effective relationships and collaborations and managing conflict within the team - Act as an expert in biotechnology manufacturing for the Operations organization, both for drug substance, drug product and devices, taking supply, quality, financial- and environment requirements into account - Plan, organize and coordinate project team activities, both for pre-studies as in project execution - Perform cost control and balance the demand for quality/scope/schedule/cost. Assess project risks with the project team, propose and follow-up mitigation and contingency plans. - Provides overall portfolio management for the Product Operations Team, and facilitates team meetings - Manage product launches, and owns the product risk management process -anticipates and mitigates risks to supply in the present and the future - Communicate the GBU Franchise vision, updates on project progress and escalates emerging issues to senior management and Project Core Team - Support the Operations organization in due diligence on licensing and acquisition opportunities as well as biotech manufacturing site assessments; Leverage a solid experience and knowledge in biotech manufacturing to support due diligence activities and provide depth and argument to Operations recommendations.   Requirements   - BS/MS in pharmaceutical, life sciences, biotech, or related field, advanced degree preferred - Minimum of 8-10 years of experience, with a minimum of 5 years' experience in biotech manufacturing of drug product, preferably with experience of auto-injectors; experience in launching a high value biologic and cold chain distribution would be pluses - Experienced biotech-pharma Product Leader/Manager with a successful track record of delivering results within agreed time, quality and cost - Strong experience leading cross-functional teams including supply, quality, regulatory affairs, CMC, procurement, process experts, packaging, and device experts - Project Management experience with excellent working knowledge of project management tools (e.g. MS Project, Smartsheet's, SharePoint, MS Teams) and processes - Strong leadership skills including communication, conflict management, and coaching - Ability to effectively engage with and influence senior stakeholders - Fluent in both written and spoken English, other languages an asset  

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New!
30/09/2022

PMS Complaints Manager

Axepta SA
Switzerland, Geneva, Genève - Axepta SA
Medical/Hospital
Other

We are looking for a PMS Complaints Lead, for one of our prestigious, world-renowned and fast-growing clients specialized in Medical Devices, located in Geneva.   Responsibilities : PMS Complaints management - Oversee the Case Management activities including triage and reportability assessment - Oversee Quality Review and Medical Case Assessment of the customer complaints - Liaise with QA Management to lead the complaints investigations management - Responsible for due diligence compliance for the compliance on reporting to the relevant competent authorities and notified body - Oversee the interactions with the local KOLs for medical assistance or any other medical assessment request - Developing and implementing KPIs related to complaints handling activities - Leading reconciliation processes with affiliate, local partners and other stakeholders e.g. EU Importer - Ensure appropriate use and maintenance of the Safety database in compliance with international regulatory authorities - Review of PSUR or other annual reports as needed Quality system maintenance in compliance with the Medical Device Regulation (2017/745) and other international applicable regulations - In charge of Training of the team for PMS Complaint handling activities for medical devices - Review and approve Safety SOPs and plans - Oversee CAPA and any findings related to the PMS Safety activities - Participate to Audit and Inspections representing the department Clinical Safety Reports management - Support processing of the clinical safety reports (pregnancy, SAE/AESI, device malfunction) as needed - Support due diligence compliance for reporting to the relevant competent authorities and Ethic Committees - Involvement in the Clinical Protocol, IB or other study documents for the PMS related sections as needed - Involvement in the review of clinical periodic (annual) reports for the specific safety sections as needed   Profile : - Pharmacist or other relevant Life-Science Master discipline e.g. Biochemistry, Biological Sciences - At least 5 years of experience in class III medical devices complaints management  - Experience in safety vigilance activities and specifically in the use of a safety database - Previous experience with people management (minimum 1 year) - Fluent in English and French   For more information, please feel free to contact Morgane CAYUELA at mc@axepta.com  

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29/09/2022

Senior Clinical QA Expert

Axepta SA
Switzerland, Vaud, Lausanne - Axepta SA
Pharmaceutical
Quality Control

My client is a growing biopharmaceutical company based in the French part of Switzerland looking to expand their quality team. Due to this growth my client is looking for a Senior Clinical QA Expert to join their team on a permanent contract based near Lausanne.   Responsabilities : - Provide QA GCP advice and support to Clinical Development/Operations functions and other relevant functions as assigned - Plan, schedule and conduct audits of Clinical Investigator Sites, Vendors, Partners/affiliates and Clinical submission documents. - Conduct GCP training for internal staff. - Assist with the maintenance of the Clinical Quality Management System including QA support for change control, deviations, review/revision of SOPs with ensuring continuous process improvement - Coordinate responses and corrective/preventative actions from deviations, audit and regulatory findings. - Stay abreast of EU clinical trial requirements, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the EU and other regions, as appropriate. - ·Alert Global QA GCP/PhV Management of internal and external GCP compliance and clinical trial issues in a timely manner. - Be knowledgeable and be able to understand advanced operational, scientific and/or clinical research areas. - Provide support for regulatory authority inspections (or audits by partner) including conducting pre-inspection audits and inspection readiness activities as assigned. Requirements - Bachelor's degree in Science or related discipline - At least 2 to 5 years' experience with GCP audits of CRO's and investigator sites. - Able to travel up to 30% at international level - Strong written and oral communication skills.

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29/09/2022

Clinical Project Manager

Axepta SA
Switzerland, Geneva, Genève - Axepta SA
Medical/Hospital
Research and Development

We are looking for a Clinical Project Manager, for one of our prestigious, world-renowned and fast-growing clients specialized in Medical Devices, located in Geneva. Be part of the young and dynamic Clinical Research Department for the implementation of clinical studies to ensure compliance with regulations (MDR, FDA...).   Responsibilities: You will be responsible for planning and managing clinical studies while respecting deadlines, budgets and quality standards. Your main responsibilities will be : - Implementation, execution and completion of company clinical research projects. - Responsible for compliance with local regulations, GCP regulations and CRO SOPs in clinical projects. - Selection and validation of investigators/sites and vendors (e.g. CROs). - Contribute to the negotiation and preparation of contracts and budgets with third parties and study sites - Ensure high quality documentation throughout the clinical study. - Manage essential clinical documentation for regulatory and ethics committee submissions in the US. - Manage CROs and ensure that they meet their time and budget commitments. - Management of clinical study budgets, including site agreements/budget. - Oversight of research organization performance and/or co-monitoring visits to sites participating in sponsored clinical projects. - Communicate regularly with sites participating in clinical projects.   Your profile: - Scientific background (e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science) - A minimum of 4 years' experience in Clinical Operations and project management (covering all stages of a clinical study) - Experience with medical devices studies - Fluent in English required / French is a plus   For more information, please feel free to contact Morgane CAYUELA at mc@axepta.com

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27/09/2022

Ingénieur Process

Axepta SA
Switzerland, Vaud, Vaud - Axepta SA
Pharmaceutical
Other

  Notre client, une entreprise spécialisée dans les dispositifs médicaux et l'un des leaders dans son domaine recherche actuellement un Ingénieur Process dans le cadre de sa croissance afin de les rejoindre sur leur site dans les environs de Lausanne.   VOS MISSIONS :   - Vous aurez la charge d'évaluer les procédés existants et de proposer des axes d'amélioration pour réduire les coûts et délais tout en gardant le même niveau de qualité. - Vous participerez au développement de la culture Lean au sein de la société. - Vous prendre part aux transferts de nouveaux produits/nouveaux équipements sur site et l'optimisation des procédés dans ce cadre. - Vous apporterez en réel leadership en terme technique sur la partie production/produits et collaborerez avec les autres départements (qualité, R&D, validation,...) pour apporter des axes d'amélioration. - Vous devrez revoir l'ensemble de la documentation incombant à votre partie. - Vous mettrez en place des KPIs et projet minutes si besoin. - Vous participerez aux analyses de risques, CAPA, non-conformité dans le respect des GMPs.   VOTRE PROFIL:   - Ingénieur en procédés avec une expérience de 6 ans sur un poste similaire au sein d'une entreprise pharmaceutique ou de dispositive médicaux. - Bonne connaissance des normes GMPs et ISO 13485. - Très bonne connaissance en production, définition des procédés et du développement, validation et amélioration continue. - Bonne communication, notamment avec la production mais également avec les autres départements. - Expérience en gestion de projet, si possible internationale. - Anglais minimum B2 et bonne connaissance IT.

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27/09/2022
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