Gxp QA Manager

vor 19 Stunden

Basel, Schweiz Idorsia Pharmaceuticals Ltd. Vollzeit

**About Idorsia Pharmaceuticals Ltd**

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.
In order to achieve this, we want to develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.
Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet - the ideal constellation to bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,100 highly qualified specialists dedicated to realizing our ambitious targets.

We are looking for an enthusiastic and motivated **GxP QA Manager** to join our dynamic team

**Job's Responsibilites**:
The GxP QA Manager is responsible for the implementation and daily oversight of QA GxP Quality
Systems and processes at Idorsia, in accordance with GxP expectations. This includes:

- Facilitate the GxP document/QA process management system adoption within Idorsia worldwide, and monitor they are properly followed in the affiliates and departments
- Manage the incoming requests for QS Documents framework modification, and make decision on integration in the Idorsia worldwide quality framework
- Oversee the GxP compliance decision of the QS Document lifecycle, including periodic reviews, translations, and training issuance periods
- Evaluate and implement modifications on the training matrix, based on organizational modifications or Idorsia departmental needs, whether at headquarter or at affiliates: identify impact on learner roles, curricula and training requirement, and decide whether the implementation does not compromise the entire Idorsia training matrix strategy and consistency
- Manage the training assignment discussion and implementation with line managers and document owners for ensuring the overall compliance of the Idorsia training framework and compliance objectives
- Identify, evaluate employee or groups needs for specific GxP courses, either at headquarter or at affiliates, and develop/coordinate development of training package, accordingly, including content, format, storage and maintenance modalities, related quizzes or any other training aspect
- Organize, and drive training and onboarding activities of the new employees, Veeva experts and any group requiring a training on QA GxP systems
- Coordinate the Veeva expert network:

- Organize regular team meetings for collecting feedbacks and sharing knowledge on expert’s activities
- Identify systemic issues raised by the expert and proposes solution for enabling improvement of expert’s activities
- Identify needs for additional experts or activities relevant for experts, proposes solutions and implement them as required
- In collaboration with the QA GxP Quality and Regulation Intelligence leader:

- support the Idorsia QS Document architecture for headquarter and affiliates: identify and implement as agreed any governance, method or processes needed for ensuring the consistency of the procedural structure is preserved across Idorsia, and for ensuring the contents of QS Documents are not overlapping
- organize and coordinate with local QA and local experts the QS Document structure for Idorsia affiliates, as well as identify the need for additional local supports
- in collaboration with QA systems Business Owner(s) and QA continuous improvement and performance manager:

- Obtain and monitor user feedback and contribute to optimizing the service
- Analyze the problems of end-users and finding appropriate solutions in collaboration with GIS / technical
- Prepare regular statistics on Quality Management System activities user support and feedback
- Own and maintain some of the QS Documents, including user manuals, describing QA owned GxP systems processes and activities, and related documentations (including training material, user manuals etc )
- Support the business owner and the system owner for the business/technical aspects of the validation and operations of QA owned GxP systems, as needed
- Support the GxP systems team during regulatory inspections or internal audits with regard to applicable QA and Quality Management computerized system(s) content and processes
- Minimum 6 years experience in quality systems, training and/or processes oversight, and including minimum 3 years experience in QA in pharmaceutical industry
- Proven tracks in procedural architecture and training management structure oversight in strongly regulated context (pharma ideally, directly on GxP projects)
- Very good knowledge of GxP regulated environments and requirements
- Good understanding of ICH Q10 and quality systems in GxP environment
- Strong communication skills, able to

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