Senior QA Manager GxP Systems
CK QLS are recruiting for a QA Manager GxP Systems to join an Innovative company based in Basel, Switzerland, on a contract basis, until the end of December 2023.
- Facilitate the GxP document/QA process management system adoption within Company 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 Company 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 Company 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 Company training matrix strategy andconsistency.
- Manage the training assignment discussion and implementation with line managers and document owners for ensuring the overall compliance of the Company 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.
- Minimum 6 years experiencein 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 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.
- Independent, and hands-on working style, team player, highly self-motivated, proactive and change oriented.
- Experienced in giving presentations and standing in front of an audience.
- Experienced in and capable of dealing with people of different cultures, educational backgrounds, and computer knowledge.
- Ability to put oneself in the position of a GxP system user, and, based on this, to shape training, answer users’inquiries accordingly and emphasize the benefits of GxP systems.
- Fluent in English (written and spoken), French and/or German is a plus.
Apply: Please could you send any correspondence in English. For more information contact Adrien Guimardat firstname.lastname@example.org or 0041 (0) 800 106106. Please quote job reference 54451 in all correspondence.