Senior QA Manager Gxp Systems
QLS are recruiting for a Senior QA Manager GxP Systems to join an important project with a global Pharmaceutical Company at their site based in Alschwil on a contract basis for 12 months.
The main purpose of the role will be: The QA manager, GxPsystems is responsible for the implementation and daily maintenance of QA GxP Quality Systems and processes at Company, in accordance with GxP expectations and for carrying out the quality control check of draft QS Documents and related DCCs (Document Change Controls) prepared using the Veeva Vault Quality workflows.
- Tasks for QA owned GxP system and process oversight:
- Tasks for QA owned GxP systems content management (QA S&P role in Veeva Vault Quality):
Further responsibilities will include:
- Ensure oversight on the implemented QA owned GxP systems in the departments and affiliates
- 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
- Based on the monitoring of the systems and processes implementations, propose improvements in any type (organizational, system related, process related) for keeping a high level of compliance and user satisfaction across Idorsia• Organize and coordinate the “Company” 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 acrossIdorsia, 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
- Manages globally the training on the GxP systems and processes:
- 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
- Identify, evaluate employee or groups needs for specific GxP courses,either at headquarter or at affiliates, and develop/coordinate development of them accordingly, including content, format, storage and maintenance modalities, related quizzes or any other training aspect
- Monitor and keep oversight on the development of GxP training materials that are not directly supported by the GxP Quality systems department
- Collect and analyze feedback from trainees and affiliates / departments for proposing training content improvement
- coordinate the revision ofGxP training courses as needed, according to the available resources and required timelines
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Master's Degree in Quality• minimum 5 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 oversightin strongly regulated context (pharma ideally, directly on GxP projects)
- Very good knowledge of GxP regulated environments and requirements
- Very good understanding of ICH Q10 and quality systems in GxP environment
- Strong communication skills, able to understand problems and present improvement and monitoring solutions to business stakeholders
- Strong influencing skills for partnering with affiliates for implementing and maintaining robust centrally managed processes
- Ability to prepare documents and communications in a clear and concise style, impactful for business stakeholders as well as technical ones
- Independent, and hands-on working style, team player, highly self-motivated, proactive and change oriented
- Fluent in English (written and spoken), French and/or German is a plus.
- Ability to work under pressure and prioritize tasks
- Ability to independently deal with complex and difficult situations
For more information or to apply for this position,please contact Adrien on 0041 (0) 800 106 106 or email firstname.lastname@example.org. Please could you send any correspondence in English. Please quote reference QLS 00051166 in all correspondence.