Senior Manager Clinical QA

vor 1 Monat


Morges, Waadt, Schweiz Incyte Vollzeit
Job Summary

This position is responsible for providing GCP oversight of Clinical Development teams to the Head of Incyte Global Pre-clinical & Clinical QA. The successful candidate will be responsible for the execution and management of Incyte QA GCP audits and the provision of GCP guidance and advice across relevant assigned Clinical Development programs.

Key Responsibilities

• Provide QA GCP advice and support to Incyte 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 Incyte 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 Clinical Upper Management of internal and external GCP non-compliance and clinical trial issues in a timely manner.

Requirements

• Bachelor's degree in a science or healthcare related discipline, or similarly conferred degree from a University
• 2 to 10 years' experience in a pharmaceutical or bio-pharmaceutical company in a GCP Quality Assurance role or Clinical compliance role
• Minimum of 1 year experience performing GCP audits of investigator sites and/or CROs or comparable GxP audits experience.
• English fluency written and spoken (the company language)
• Knowledge of other language such as French is an asset
• Ability to travel up to 30%
• Prior GCP Regulatory inspection experience would be a plus
• Strong written and oral communication skills

  • Morges, Waadt, Schweiz Incyte Vollzeit

    Job SummaryThis position is responsible for providing GCP oversight of Clinical Development teams to the Head of Incyte Global Pre-clinical & Clinical QA. Key responsibilities include executing and managing Incyte QA GCP audits, providing GCP guidance and advice across assigned Clinical Development programs, and conducting GCP training for Incyte staff.Key...


  • Morges, Waadt, Schweiz Incyte Vollzeit

    Job Summary:We are seeking a highly skilled Regulatory Compliance Specialist - Clinical QA to join our team at Incyte. The successful candidate will be responsible for providing GCP oversight of Clinical Development teams and executing and managing Incyte QA GCP audits.Key Responsibilities:Provide QA GCP advice and support to Incyte Clinical...


  • Morges, Waadt, Schweiz Incyte Vollzeit

    Job SummaryWe are seeking an experienced Clinical QA professional to join our team as a Senior Manager of Clinical QA. This role will provide GCP oversight of Clinical Development teams, execute and manage Incyte QA GCP audits, and provide GCP guidance and advice across assigned Clinical Development programs.Key ResponsibilitiesProvide QA GCP advice and...


  • Morges, Waadt, Schweiz Incyte Vollzeit

    OverviewThis role plays a vital part in ensuring the quality and integrity of clinical trials within Incyte. The Senior Manager Clinical QA will provide GCP oversight to Clinical Development teams and execute audits to ensure compliance.Duties and ResponsibilitiesProvide GCP advice and support to Incyte Clinical Development/Operations functions.Plan,...


  • Morges, Waadt, Schweiz Incyte Vollzeit

    Job SummaryThe Senior Manager Global Quality Compliance and Performance is a key member of the Global Quality team responsible for ensuring the oversight of Incyte Quality compliance and driving quality performance across various GxP disciplines, including pre-clinical and clinical development, manufacturing, and distribution, as well as post-marketing...


  • Morges, Waadt, Schweiz Incyte Vollzeit

    Job Summary:Spearhead quality compliance and performance initiatives at Incyte, driving oversight and strategic documentation in the Global Quality team. Develop and maintain quality risk management programs, ensuring GxP discipline compliance across pre-clinical, clinical, manufacturing, and post-marketing surveillance. Collaborate with QA and operational...


  • Morges, Waadt, Schweiz Fondation de La Côte Vollzeit

    About the RoleAs a Senior Software Engineer (Backend), you will be responsible for designing, developing, and maintaining high-quality backend systems. This includes working closely with cross-functional teams to identify and prioritize project requirements, developing technical roadmaps, and ensuring the scalability and reliability of our systems.Key...


  • Morges, Waadt, Schweiz Incyte Vollzeit

    About the RoleThe Manager/Senior Manager Global Quality Compliance and Performance is a key member of the Global Quality team responsible for ensuring the oversight of Incyte Quality compliance and driving quality performance across various GxP disciplines. This position develops and maintains strategic Quality documentation, including the Quality Manual and...


  • Morges, Waadt, Schweiz Incyte Vollzeit

    Job SummaryReporting to the VP, External Biologics Manufacturing, this position will provide analytical support to commercial manufacturing performed externally at contract organizations. The successful candidate will work closely with the Director, External QC Commercial Biologics, and will be actively engaged with collaborators/partners, CMOs, and...


  • Morges, Waadt, Schweiz Incyte Vollzeit

    Job Title: Senior Administrative CoordinatorAbout the Role:We are seeking an experienced Senior Administrative Coordinator to support our Executive Director, Business Lead IAI in Europe. This is a temporary contract position that requires strong organizational and communication skills.Duties and Responsibilities:As a Senior Administrative Coordinator, you...


  • Morges, Waadt, Schweiz Incyte Vollzeit

    About the RoleWe are seeking an experienced Senior Quality Assurance Manager to join our team in the Commercial Biologics Development department at Incyte. The successful candidate will be responsible for ensuring the quality and compliance of our biologics products throughout their lifecycle.Key Responsibilities:Manage and support the timely and effective...


  • Morges, Waadt, Schweiz Incyte Vollzeit

    Job SummaryAs a Senior Manager of External Commercial Biologics Quality Control, you will be responsible for providing analytical support to commercial manufacturing performed externally at contract organizations. You will work closely with the Director, External QC Commercial Biologics, and be actively engaged with collaborators/partners, CMOs, and...


  • Morges, Waadt, Schweiz Accuray Vollzeit

    Service & Installed Base Product Manager EIMEAAt Accuray, we are looking for a highly skilled and motivated individual to join our team as a Service & Installed Base Product Manager EIMEA. The successful candidate will be responsible for developing and executing the service and installed base marketing plan for the EIMEA region.Key Responsibilities:Develop...


  • Morges, Waadt, Schweiz Incyte Vollzeit

    Quality Compliance and Performance Manager Job SummaryThe Quality Compliance and Performance Manager is a key member of the Incyte Quality team, responsible for ensuring the company's compliance with global quality standards and regulations.Key ResponsibilitiesQuality Risk Management (QRM)The Quality Compliance and Performance Manager will develop,...


  • Morges, Schweiz Incyte Vollzeit

    Overview Summary This position is responsible for providing GCP oversight of Clinical Development teams to the Head of Incyte Global Pre-clinical & Clinical QA. This job will include the execution and management of Incyte QA GCP audits and the provision of GCP guidance and advice across relevant assigned Clinical Development programs. Duties and...

  • Clinical Trial Manager

    vor 5 Monaten


    Morges, Schweiz Incyte Corporation Vollzeit

    **Summary** The position is accountable for the management of all aspects of Incyte sponsored clinical trial(s). The responsibilities would include (non-exhaustive): (1) Provide input to the overall operational trial(s) strategic implementation; (2) Manage full trial(s) execution within agreed timelines and budget, (feasibility, country identification,...


  • Morges, Schweiz Incyte Corporation Vollzeit

    Overview: SUMMARY The Manager, Commercial Manufacturing QA is responsible for the Quality oversight of commercial manufacturing activities associated with Drug substance, Drug Product and Britestock. He/She assures compliance of assigned registered products throughout their lifecycle, with cGMP requirements and registration files. He/She is responsible of...


  • Morges, Schweiz Incyte Corporation Vollzeit

    Aperçu: Summary The Manager/Senior Manager Global Quality Compliance and Performance is a member of the Global Quality team assuring the oversight of Incyte Quality compliance and driving quality performance at Incyte, spanning the different GxP disciplines (pre-clinical and clinical development, manufacturing and distribution, post marketing...


  • Morges, Schweiz Incyte Vollzeit

    Overview Summary The Manager/Senior Manager Global Quality Compliance and Performance is a member of the Global Quality team assuring the oversight of Incyte Quality compliance and driving quality performance at Incyte, spanning the different GxP disciplines (pre-clinical and clinical development, manufacturing and distribution, post marketing...


  • Morges, Schweiz Incyte Corporation Vollzeit

    Overview: Summary The Senior Medical Director, Global Risk Management & Safety Surveillance (GRMSS) will be responsible for developing and ensuring execution of all patient safety risk management activities for molecular entities under clinical development as well as for Incyte marketed products. This will include pharmacovigilance activities and...


  • Morges, Schweiz Incyte Corporation Vollzeit

    Overview: **SUMMARY** The Intern will be part of the Small Molecule (SM) Commercial Manufacturing QA team responsible for the Quality oversight of commercial manufacturing activities associated with SM Drug substance, Drug Product and primary packaged Product. He / She will contribute to the maintenance and compliance of Incyte Quality Management...


  • Morges, Schweiz Incyte Corporation Vollzeit

    Overview: Job Summary (Primary function) The _Global Risk Management and Safety Surveillance (GRMSS) Portfolio Manager_ is responsible for covering Pharmacovigilance (PhV) activities throughout Incyte products lifecycle management (other than Case management) for complete set-up, maintenance and closeout of Incyte programs. The position is responsible for...


  • Morges, Schweiz Incyte Corporation Vollzeit

    OverviewThis is a great position within a promising therapeutic area that includes innovative medicine in Inflammation and Autoimmunity (IAI) and more in particular in Dermatology.This is the accountable leadership position in Medical Affairs Region Europe for IAI. This person will lead the Medical Affairs IAI team in Regional Headquarters (HQ) & have dotted...


  • Morges, Schweiz Incyte Biosciences International Sàrl Vollzeit

    Job DescriptionOverviewSummaryThis is a great position within a promising therapeutic area that includes innovative medicine in Inflammation and Autoimmunity (IAI) and more in particular in Dermatology.This is the accountable leadership position in Medical Affairs Region Europe for IAI. This person will lead the Medical Affairs IAI team in Regional...


  • Morges, Schweiz Incyte Corporation Vollzeit

    Overview: Summary This is a great position within a promising therapeutic area that includes innovative medicine in Inflammation and Autoimmunity (IAI) and more in particular in Dermatology. This is the accountable leadership position in Medical Affairs Region Europe for IAI. This person will lead the Medical Affairs IAI team in Regional Headquarters (HQ) &...


  • Morges, Schweiz Incyte Corporation Vollzeit

    Aperçu: **Summary** Reporting to VP, External Biologics Manufacturing, this position will be responsible for analytical support to commercial manufacturing performed externally at contract manufacturers. This position will work closely with the Director, External QC Commercial Biologics and will be actively engaged with collaborators/partners, CMOs, and...


  • Morges, Schweiz Incyte Vollzeit

    Aperçu Summary Reporting to VP, External Biologics Manufacturing, this position will be responsible for analytical support to commercial manufacturing performed externally at contract position will work closely with the Director, External QC Commercial Biologics and will be actively engaged with collaborators/partners, CMOs, and interface with...

  • Logistics Supervisor

    vor 5 Monaten


    Morges, Schweiz Accuray Vollzeit

    Give hope. Give health. Make your mark in the fight against cancer. At Accuray, we make a direct and powerful impact on the lives of cancer patients every day — helping them live longer, better lives. But our commitment to innovation offers a truly unique opportunity: the chance to change the fight against cancer — helping to develop, introduce and...


  • Morges, Schweiz Incyte Corporation Vollzeit

    Overview: SUMMARY The Senior Director is responsible for the overall supervision of Incyte supply chain security and anti-counterfeiting program, applicable to all commercial products (large and small molecules one). The incumbent will oversee, manage and coordinate internal and external activities; communicate and work with several partners and...

  • Corporate EHS

    vor 6 Monaten


    Morges, Schweiz Incyte Corporation Vollzeit

    Overview: Incyte is a rapidly growing biotechnology company committed to pioneering innovation in life sciences. Our mission is to make a meaningful impact on healthcare and the environment through cutting-edge research and development. As we expand our operations in Europe, we are seeking a forward-thinking, creative, and entrepreneurial EHS Corporate...


  • Morges, Schweiz Lunaphore Technologies, S.A. Vollzeit

    Order Management SpecialistLocation: Tolochenaz, SwitzerlandTime Type: Full timePosted On: Posted YesterdayJob Requisition ID: JR100123By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for...

  • Senior IAM Engineer

    vor 2 Monaten


    Morges, Schweiz Randstad Vollzeit

    Description du posteResponsabilités principales :-Développer et étendre la plateforme Identity and Access Managementà travers «One Identity Manager»- Analyser et intégrerdes systèmes complexes dans le domaine de l’Identity and AccessManagement (IAM)- Optimiser et développer lesinfrastructures IAM existantes- Contribuer àl’élaboration et à la...


  • Morges, Schweiz Incyte Corporation Vollzeit

    SUMMARY The Executive Director is responsible for the overall supervision of Incyte supply chain security and anti-counterfeiting program, applicable to all commercial products (large and small molecules one). The incumbent will oversee, manage and coordinate internal and external activities; communicate and work with several partners and functions;...


  • Morges, Schweiz Eaton Vollzeit

    **What you’ll do**: Work with senior leaders from the Electrical Sector; the EMEA regional leadership and individual business units; Corporate Development & Planning (CD&P); and others on the Strategy and Business Development team to identify inorganic growth opportunities and help execute acquisitions and investments supporting Eaton’s Electrical Sector...