Global Quality Training Lead

Global Manager, Training Quality Lead

In this role, you will drive the overall management of Procedural Document Management and Training Management activities throughout a leading Biopharma located in Switzerland. You will build a collaborative working relationship & partner with the business partners and cross-functional Quality Peers. Your responsibilities will be but not limited to:

DOCUMENT MANAGEMENT

• Evaluate, design, optimise & implement the DPI Procedural Document.
• Partner with critical quality & business representatives to drive the newly Quality Management System module.
• Partner with Process Owners to design & implement well-defined process, ensuring integration of people, process, and system components in business critical ProcDocs.
• Act as a change agent supporting compliance and continuous improvement of critical business processes.
• Ensure proper CAPA & KPI are developed and monitored.

LEARNING MANAGEMENT

• Evaluate, design, optimise, implement the DPI Training & Learning Strategy and System in alignment with business objectives.
• Partner with critical quality & business representatives to drive the set up and implementation of the newly QMS module, more specifically Learning Management System
• Establish and drive an effective role-specific learning and development structure and “just in time knowledge management” to enable the desired business results.
• Identify, evaluate, assess, and select external training vendors ensuring effective availability of effective training programs on specific topics.
• Work with the Quality Leads to create and execute on engaging eLearning, instructor-led learning, virtual instructor-led learning based on experience from audit, inspection, CAPA and other sources.

Your profile

• Master’s degree in a scientific discipline or equivalent combination of education and experience.
• Preferably 15 years’ experience in the Pharmaceutical or Biotechnology industry with a solid experience of at least 8-10 years in QMS in a GxP environment.
• Experience in understanding global regulatory GxP requirements and industry trends with the ability to apply them to process improvement.
• Experience in supporting Regulatory Inspection and Due Diligence activities.
• Significant experience with QMS tools, more specifically Procedural Document Management System and Learning Management System.
• Used to simultaneously support multiple projects, duties and assignments and prioritise accordingly.
• Proficiency in English (C1 Oral & written), fluent French is an asset.