Job Description
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.
About The Customer
* Start: ASAP
* End: 31.08.2026 with possible extension
* Location: Neuchatel
* Workload: 100%
Requirements
* 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
Competences
* 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
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