Aurélia Stampfler Email & Phone Number

Basel, Bs, Ch

Basel, Switzerland

• Led and implemented transformative initiatives to strengthen the global Quality Management System (QMS), optimizing processes across GxP domains (GMP, GDP, GCP & GVP), including the implementation of Global Process Owners at Sobi, Quality Risk Management and Change Control processes.• Act as a liaison for RDMA and affiliates to provide guidance, support, and trainings to ensure the implementation of robust process frameworks and alignment.• Support proactive identification of needs for process standardization, regulatory compliance and areas for improvement.• Provide comprehensive end-to-end support to global business process owners, facilitating decision-making on process improvement initiatives, and overseeing their implementation, including robust change management strategies.• Raise awareness and understanding of the process requirements to the senior management.• Support the global and local process owners by working with other stakeholders to identify systemic process related issues/risks, training or process improvement needs from deviation trends, findings in audits & inspection reports to drive corrective and preventative actions.• Act as a change agent by partnering with key stakeholders to drive quality culture and embed a continuous improvement mindset.• Represent Quality on process related taskforces/working groups in collaboration with the process owners.Implementation of Veeva QMS:• Led the sprints for the Veeva QMS Change Control module and RIM Connector, and coordinated cross functional alignment and decision making.• Designed and implemented a Super User Framework• Contributed to the Veeva QMS Risk Assessments by identifying, mitigating and reviewing risks• Designed and implemented the overall Veeva training strategy in partnership with the training administrators• Improved the global communication strategy• Support the transition and hyper-care for both Veeva and the Procedures

Basel, Switzerland

Basel, Switzerland

• Drives the global GCP/GVP training strategy • Accountable for implementation and development of PD and Affiliates quality mindset in the context of training management• Responsible for the development and sustainability of a quality network (at local and global level) aimed to strengthen Roche knowledge management• Responsible for continuous improvement projects within PDQS team with a risk based approach• Inspires, coaches and empowers a cross-cultural team of employees and contractors to simplify, mature and innovate the GCP/GVP Quality Management system• Responsible for PDQS Inspection Readiness & Management strategy and execution

Basel Area, Switzerland

• Acted as Quality Responsible for PD Global Training process and mitigate emerging compliance gaps• Acted as Global GCP/GVP training program owner: responsible for business continuity, alignment with strategic decisions and continuous improvement • Defined and implemented training delivery strategy aimed at eliminating duplication and improving efficiency for Roche Pharma• Implemented centralised and simplified training processes for Affiliates involving establishing, maintaining and fostering strong partnership with key Quality partners.• Led a compliance task force involving advising and supporting senior PD stakeholders from Quality Councils member to define and implement Just in Time training strategy for GCP/GVP training area• Definition and implementation of Just in Time training strategy for GCP/GVP training area• Ensured Inspection Readiness by defining and implementing PDQS role in inspection support strategy. Acted as single point of contact for Inspections.• Hired, on boarded and supervised a team of contractors to support the implementation of the global GCP/GVP training strategy

Basel Area, Switzerland

• Led a cross-organisational Data Workstream team for the implementation of a new company-wide Learning Management System in PD and the Affiliates• Collaborated with business areas for the management of training within the Learning Management Systems, and maintenance and update of role based training curricula.• Ensured appropriate rollout of Global GxP training plans in the learning management systems • Developed and implemented the Global GCP/GVP training compliance metrics strategy for PD and Affiliates

Basel, Switzerland

• Developed and implemented standardised document management processes• Designed and released e-Learning modules for PD and Affiliates• Established and maintained a network of system administrators• Provided document management process and system support to end users.

Basel, Switzerland

• Instructional Design: development of eLearning modules for Pharma Development; development and implementation of standard templates for procedural document trainings. • Developed and implemented a learning strategy through Webcasting• Updates of Procedural Documents.• Planning and organisation of training events.

Sydney, Australia

• Supported the development of the business by conducting thorough market research• Ensured high quality recruitment process, from the definition of the job description to the interviews of candidates

Master'S Degree, Cross Cultural Management And International Business Administration

Cross-cultural Management and International Business Administration with a specialization in Japanese culture.

3-Year University Degree, Business Administration

Diploma in Management, IUP Sciences des Gestion en Affaires Internationales – equivalent to a 3-year university degree in Business.