Quality Compliance Specialist

Start: ASAP

End: 31.08.2026 with possible extension

Location: Neuchatel

Workload: 100%

We are currently looking for an experienced Quality Compliance Specialist to join the Quality organization of a leading biopharmaceutical company in Neuchatel. In this role, you will be part of the Quality Compliance & Systems team and play a key role in GMP self-inspections, data integrity, and inspection readiness activities.

This is an exciting opportunity for a senior QA professional who enjoys cross-functional collaboration, audit environments, and driving continuous improvement within a GMP-regulated setting.

• Act as QA representative for routine GMP Self-Inspection activities
• Maintain and continuously improve the self-inspection system
• Define and implement a risk-based self-inspection schedule in collaboration with site leadership
• Plan, coordinate and support internal, corporate and external GMP audits
• Participate as backroom (ACC) or Scribe member during audits
• Perform gap assessments on new or revised global procedures
• Ensure inspection readiness across departments including Production, QC, Warehouse and Engineering
• Deliver coaching sessions to SMEs and audit teams
• Act as local Data Integrity Champion and ensure strong collaboration with global teams
• Prepare, analyse and present compliance topics at Quality Council
• Support continuous improvement initiatives within the compliance team
• Act as back-up to the Head of Quality Compliance & Systems when required
• Ensure adherence to EHS guidelines and promote a strong safety culture

• University degree in a scientific or technical discipline such as Biochemistry, Chemistry or Engineering
• Minimum 7 years of experience in the biotechnology and or pharmaceutical industry
• Strong knowledge of GMP environments
• Good understanding of manufacturing, laboratory testing and warehousing operations related to biological products
• Solid knowledge of GDDP and Data Integrity principles
• Experience in creating, reviewing and revising SOPs and technical documentation
• Experience supporting regulatory inspections and audits
• Familiarity with risk management tools such as FMEA and root cause analysis
• Proficiency in French and English (minimum B2 level)
• Experience with electronic quality management systems such as Veeva Vault or TrackWise
• Strong MS Office skills and experience with reporting tools such as Power BI