Senior Manager Clinical QA
Vor 4 Tagen
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.
- 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.
-
Senior Manager Clinical QA
Vor 4 Tagen
Morges, Schweiz Incyte VollzeitOverview 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...
-
Manager Clinical QA
vor 1 Woche
Morges, Schweiz Incyte Corporation VollzeitSummary 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 VollzeitSummary 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 VollzeitIncyte 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...
-
Morges, Schweiz Incyte Corporation VollzeitOverviewSummaryThis 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...
-
Morges, Schweiz Incyte Biosciences International Sàrl VollzeitJob 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...
-
Morges, Schweiz Incyte VollzeitOverviewSummaryThis 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...
-
Morges, Schweiz Incyte Corporation VollzeitAperçu: 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 TN Switzerland VollzeitManager/ 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...
-
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...
-
Morges, Schweiz Incyte VollzeitOverview 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 VollzeitIntern - 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 VollzeitMandat 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 VollzeitMandatés 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 VollzeitJob 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 VollzeitSr 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 VollzeitAperçu 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 VollzeitAperçu: 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...
