Senior Manager Clinical QA

Vor 4 Tagen

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 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.

·Be knowledgeable and be able to understand advanced operational, scientific and/or clinical research areas. Be thoroughly familiar with assigned Incyte compounds and protocols.

·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 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

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

We Respect Your Privacy

Learn more at:

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. 

You can learn more about Incyte’s data protection practices . By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).

Please contact privacy@ if you have any questions or concerns or would like to exercise your rights.

  • Senior Manager Clinical QA

    Vor 4 Tagen

    Morges, Schweiz TN Switzerland Vollzeit

    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 ResponsibilitiesProvide QA GCP...

  • Manager Clinical QA

    vor 1 Woche

    Morges, Schweiz Incyte Corporation Vollzeit

    Summary This position is responsible for providing GCP oversight of Clinical Development teams to the Head of Incyte Global Clinical/PhV 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. **Position Location**: Switzerland...

  • Manager - Sr Manager Clinical QA

    Vor 2 Tagen

    Morges, Schweiz Incyte Corporation Vollzeit

    Summary The Sr GCP Auditor is responsible for providing primarily ex-US Pharmacovigilance (PVG) audit support for QA management and oversight of global PVG activities of Clinical Development teams to the Head of Incyte QA-GCP. Secondarily the Sr Auditor is responsible for GCP support for clinical development. This job will include the execution and...

  • Sr Manager, Global Clinical Supply Chain

    vor 2 Wochen

    Morges, Schweiz Incyte Corporation Vollzeit

    **Job Summary **(Primary function) The Senior Manager, Clinical Supply Chain manages the clinical supply activities for assigned clinical programs. The Senior Manager develops and maintains clinical supply plans to include investigational products and co-meds ensuring accurate and continuous supply to assigned clinical programs while reducing risk and...

  • Clinical Trial Manager

    Vor 3 Tagen

    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,...

  • Manager, Clinical Data Management

    Vor 7 Tagen

    Morges, Schweiz Incyte Corporation Vollzeit

    Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and...

  • Senior Director/ Director, Clinical Research Scientist

    vor 1 Woche

    Morges, Schweiz Incyte Biosciences International Sàrl Vollzeit

    Job DescriptionOverviewSummaryThis position is responsible for working with the physicians and other clinical scientists within Early Clinical Development to provide clinical research support for early phase clinical programs as assigned by therapeutic area and type of therapy. Primary focus will be on I&I programs.Duties and ResponsibilitiesDevelopment of...

  • Senior Director/ Director, Clinical Research Scientist

    Vor 3 Tagen

    Morges, Schweiz Incyte Corporation Vollzeit

    OverviewSummaryThis position is responsible for working with the physicians and other clinical scientists within Early Clinical Development to provide clinical research support for early phase clinical programs as assigned by therapeutic area and type of therapy. Primary focus will be on I&I programs.Duties and ResponsibilitiesDevelopment of protocols for...

  • Senior Director/ Director, Clinical Research Scientist

    vor 1 Woche

    Morges, Schweiz Incyte Vollzeit

    OverviewSummaryThis position is responsible for working with the physicians and other clinical scientists within Early Clinical Development to provide clinical research support for early phase clinical programs as assigned by therapeutic area and type of therapy. Primary focus will be on I&I programs.Duties and ResponsibilitiesDevelopment of protocols for...

  • Manager/ Sr Manager Global Quality Compliance and

    Vor 7 Tagen

    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...

  • Manager/ Sr Manager Global Quality Compliance and Performance, Morges

    Vor 4 Tagen

    Morges, Schweiz TN Switzerland Vollzeit

    Manager/ Sr Manager Global Quality Compliance and Performance, MorgesClient: IncyteLocation: MorgesJob Category: OtherJob Reference: a9d3c65acb49Job Views: 9Posted: 21.01.2025Expiry Date: 07.03.2025Job Description:OverviewThe Manager/Senior Manager Global Quality Compliance and Performance is a member of the Global Quality team assuring the oversight of...

  • Medical Director/sr Medical Director Early Clinical

    Vor 7 Tagen

    Morges, Schweiz Incyte Corporation Vollzeit

    **Summary** This position is responsible for implementing clinical drug efforts for Incyte's oncology products (Phase I though POC) for oncology. **Duties and Responsibilities**: - Provides medical and scientific expertise for internal cross-functional team members for development of specific anti-neoplastic agents including discovery scientists, medical...

  • Manager/ Sr Manager Global Quality Compliance and Performance

    Vor 5 Tagen

    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...

  • Intern - Commercial Manufacturing Quality Assurance

    vor 1 Woche

    Morges, Schweiz Incyte Corporation Vollzeit

    Intern - Commercial Manufacturing Quality AssuranceOverviewSUMMARYThe 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...

  • Senior Financial Planning

    Vor 3 Tagen

    Morges, Schweiz Pouly Tradition Vollzeit

    Mandat és par l'un de nos clients, nous sommes actuellement à la recherche d'un(e) Senior Financial Planning & Analytics AnalystYour mission :In this role, you will support the international region with P&L management, analytics, budgeting, and forecasting, collaborating with business leaders. The position is based in Morges, reporting to the Associate...

  • Senior Financial Planning

    Vor 5 Tagen

    Morges, Schweiz Manpower SA Vollzeit

    Mandatés par l'un de nos clients, nous sommes actuellement à la recherche d'un(e) Senior Financial Planning & Analytics AnalystYour mission :In this role, you will support the international region with P&L management, analytics, budgeting, and forecasting, collaborating with business leaders. The position is based in Morges, reporting to the Associate...

  • Training Optimization Process Manager

    Vor 7 Tagen

    Morges, Schweiz Incyte Corporation Vollzeit

    Job Summary _(Primary function)_ Coordinate training content creation, process design and delivery modes and timing of non-GxP trainings for relevant employees and contractors in Europe to ensure consistency and a coordinated cross functional approach to optimize employee (including new hire) experience and maximize effectiveness of training in the...

  • Sr Manager QC External Commercial Biologics

    Vor 3 Tagen

    Morges, Schweiz TN Switzerland Vollzeit

    Sr Manager QC External Commercial Biologics, MorgesClient:IncyteLocation:MorgesJob Category:OtherJob Reference:ea72e9c228a7Job Views:9Posted:21.01.2025Expiry Date:07.03.2025Job Description:SummaryReporting to VP, External Biologics Manufacturing, this position will be responsible for analytical support to commercial manufacturing performed externally at...

  • Sr Manager QC External Commercial Biologics

    Vor 4 Tagen

    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...

  • Administrative Assistant 50-60%

    Vor 3 Tagen

    Morges, Schweiz Incyte Corporation Vollzeit

    Aperçu: Administrative Assistant 50-60% - temporary 12 months Translated Description: **Summary** Primary administrative support for Research and Development Departments based in Morges office (Clinical Development, Development Operations, Regulatory Affairs, Pharmaco-vigilance, Global Medical Affairs and others) **Duties and...