Compliance Excellence Specialist

Join Our Team as a Compliance Excellence Specialist (P2)

At Schachen, we pride ourselves on being a vibrant hub that celebrates diversity, fosters inclusion, and empowers every employee to contribute to our collective success. Our facility is a state-of-the-art biotech center that integrates advanced technologies into the early-stage clinical pipeline, preparing innovative solutions for future commercial launches. We specialize in biologics drug substance manufacturing for early-phase clinical supply and serve as a pivotal center for technological innovation and strategic growth.

The Compliance Excellence Specialist (P2) plays a crucial role in ensuring operational compliance and quality system activities for GMP biologics manufacturing at Schachen. This position is instrumental in achieving right-first-time execution and maintaining inspection readiness by supporting investigations, documentation, change controls, risk assessments, and continuous improvement initiatives within designated areas.

Key Responsibilities

• Compliance Support & Issue Resolution
  • Assist in resolving GMP deviation records, conduct investigations, impact assessments, and CAPAs.
  • Use standard procedures and GMP expectations to assess issues and recommend actions with guidance.
  • Contribute to root cause analysis and CAPA definition by preparing inputs, gathering data, and documenting outcomes.
  • Promptly escalate risks, delays, or uncertainties in a structured manner.
• Change & Risk Management
  • Support GMP product-related change controls and risk documentation under guidance.
  • Gather and prepare essential information for risk assessments, change evaluations, and implementation planning.
  • Ensure completion of assigned documentation tasks accurately and on schedule.
  • Contribute to compliant and efficient execution of changes within your area of responsibility.
• Operational Support
  • Provide compliance support for production-related inquiries, documentation, and follow-ups.
  • Assist Manufacturing teams in resolving both standard and complex requests as needed.
  • Collaborate with colleagues across departments to gather input and align next steps.
  • Help ensure that operational decisions are consistent with GMP standards.
• Performance Management & Continuous Improvement
  • Assist in monitoring and tracking quality, compliance, and operational performance indicators.
  • Contribute to data collection, trend analysis, and preparation of performance updates.
  • Identify improvement opportunities within assigned tasks and propose practical solutions.
  • Participate in operational excellence activities such as Gemba, 5S, and other process improvement routines.
• Inspection Readiness & Quality Systems
  • Support inspection readiness by ensuring GMP documentation, deviations, investigations, and changes are thorough, accurate, and ready for inspection.
  • Participate in preparedness activities for internal audits, external audits, and regulatory inspections.
  • Maintain assigned records and documentation per procedural and compliance requirements.
  • Assist subject matter experts during audits or inspections as needed.
• Project Support & Collaboration
  • Contribute to small projects, subteams, or workstreams with appropriate guidance.
  • Complete assigned project tasks according to established timelines and expectations.
  • Build effective relationships with colleagues in Manufacturing, Quality, Engineering, and MSAT.
  • Learn actively from experienced team members and contribute to knowledge sharing.

Your Profile

• Bachelor’s or Master’s degree in a scientific, engineering, or technical discipline.
• Initial experience in GMP-regulated manufacturing, quality systems, or technical operations.
• Solid understanding of GMP expectations, documentation standards, and quality processes, with a commitment to further developing expertise.
• Ability to analyze issues following standard procedures and propose informed solutions.
• Strong collaborative skills and capability to engage with colleagues across various departments.
• Proficient communication skills in both German and English.

About Our Company

Our company is a leading biopharmaceutical entity with over 1,000 employees across three locations in Switzerland, headquartered in Lucerne. Our Zurich site serves as a global hub for innovation and development, while our Schachen facility supports the manufacturing of medicines for clinical trials, as well as operating a forensic laboratory. We conduct around 40 clinical trials annually in Switzerland, with key therapeutic areas encompassing oncology, infectious diseases, cardiovascular, and cardiometabolic conditions. Additionally, we hold a strong portfolio of vaccines and are a significant player in veterinary medicine. Our commitment to the local community is reflected in our longstanding participation in initiatives like «Trendtage Gesundheit Luzern» and the «Alliance Health Competence».

Company Recognition

We are honored to be recognized as a “Top Employer Switzerland” and “Top Employer Europe,” reflecting our unwavering commitment to our employees and our community.

Our Werthenstein BioPharma site in Schachen is dedicated to the forefront of research, development, and analysis of new biological agents, while also supplying clinical trial products for global studies. This facility houses one of our global forensic laboratories, vigilant in ensuring product security and safety throughout the supply chain.

Apply Online

To join our dynamic team, apply online using the form below. Please note that only applications matching the job profile will be considered.

Additional Information

• Relocation: None
• Visa Sponsorship: None
• Travel Requirements: 10%
• Flexible Working Arrangements: Onsite
• Shift: No
• Valid Driver License: No
• Hazardous Materials: No