Overview
Validation and Quality Lead Jobs in Berne, Switzerland at TMC
Title: Validation and Quality Lead
Company: TMC
Location: Berne, Switzerland
We are currently looking for several positions for a validation and computerized systems qualification project. The positions are open across leadership, execution, and specialist tracks.
Position 1: Validation/Quality Lead
Experience required: 10+ years
Acting as both Validation Lead and Quality Lead on the project.
Validation Lead responsibilities:
- Computerized System Validation (CSV) / Computer Software Assurance (CSA) activities oversight
- Validation strategy definition
- Deviation and CAPA management
- Review and approval coordination of validation deliverables
- System lifecycle management and maintenance
- Maintenance and management of system inventories
- Governance
Quality Lead responsibilities:
- Primary organizational interface, alongside the Project Manager
- Monthly Steering Committee meetings with executive stakeholder reporting
- Weekly operational status reporting and KPI dashboards
- Formal issue escalation matrix and resolution timelines
- Resource management plan ensuring continuity across project phases
- Annual performance reviews against contracted SLAs and KPIs
Position 2: Senior C&Q Engineer
Experience required: 7+ years
Role type: Execution lead
Responsibilities:
- DQ, IV, OV, PQ
- FAT/SAT support
- Verification execution
- Vendor package assessment
- Turnover package review
Position 3: CSV Specialist
Experience required: 7+ years
Role type: Validation lead
Responsibilities:
- CSV lifecycle execution
- CSA implementation
- RTM generation
- Risk assessments review
- Test strategy execution
- MES/DCS/PCS validation support
Requirements common to all positions
- Working knowledge of Kneat, Veeva, and TrackWise (basic level accepted; additional training provided directly by the client)
- German-speaking, based in Switzerland (mandatory)
| WHAT CAN YOU EXPECT FROM TMC?
TMC is an international high-tech consultancy company that brings expertise to its clients to support them in realizing their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients, and we help them to be more competitive in an ever more global and faster-changing technological world.
At TMC, people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive. We offer you a challenging and stimulating work environment in which you can be the director of your career.
As an Employeneur, you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.
| WHY CHOOSE FOR EMPLOYENEURSHIP?
We are truly unique thanks to our Employeneurship model, which is a true innovation for the high-technology consulting business. It is the business relationship of the 21st century for highly skilled technical professionals. It is built around 5 main pillars:
- You will have a permanent employment contract, offering you stability and security.
- You will get to know your market value and have a share in the profit your work generates, thanks to the individual profit-sharing.
- We will support you with one-on-one coaching and training designed to help you develop your entrepreneurial skills.
- The competence cell structure provides you with a strong, meaningful, and relevant network.
- The entrepreneurial lab: a playground for new ideas and a potential launch for start-ups.
