Senior Manager QA Compliance & Systems (a), 100 % — Bachem AG

Full description

The Bachem Group is investing in a new location in Sisslerfeld in northwestern Switzerland. This step is part of the long-term strategy to expand production capacity by the end of the decade. The new production site will play a central role in achieving these goals. The design phase of the project offers you unique opportunities to help shape the future organization. To strengthen our team in the Global Quality Department Sisslerfeld, we are looking for a dedicated Senior Manager QA Compliance & Systems (a), 100%. Your tasks:

• Planning, setting up, leading and further developing the Quality Systems and Compliance organizational unit at the Sisslerfeld site
• Monitoring the changing pharmaceutical legislation and its internal implementation at Bachem
• Supporting the coordination of the activities of internal and external parties to ensure the timely achievement of project milestones
• Setting up and implementing the quality management systems and processes and their continuous improvement
• Definition of quality-relevant key figures as well as planning and carrying out the quality management review with the active involvement of the site management
• Ensuring compliance with regulatory requirements, such as Good Manufacturing Practice (GMP)
• Creation, review and approval of site master files, policies & SOPs etc. in the department as well as coordination with global processes
• Contact and interaction with Swissmedic, Regional Therapeutic Products Institute and other relevant authorities (e.g. Submission of change reports, planning of authority inspections, etc.)
• Planning, coordination and execution of mock audits and self-inspections as preparation for achieving the "site license" and for checking compliance with quality standards
• Presentation of the department's QM processes during customer audits and authority inspections
• Responsible for the implementation of the implementation of training courses for employees in relation to quality management and regulatory requirements
• Collaboration and support of global quality management projects in the Quality Systems and Compliance Department
• Collaborate with stakeholders at all levels of the organization to ensure coordination and support of improvement initiatives
• Ability to always think outside the box in the existing market, continue training and anticipate new Q-relevant challenges in the coming years
• Ensuring cGMP compliance with the relevant regulatory requirements and the quality assurance system
• Promoting a quality culture within the organization by setting an example
• Taking on other/additional tasks as instructed
• Responsible for the E