Quality Compliance Specialist (m/f/d) Freelance/temporary employment for a project Neuchatel Start date: asap Reference number: 864224/1 Responsibilities * Lead and continuously improve the GMP self-inspection program, including annual planning and execution * Coach SMEs and audit teams to ensure strong inspection and self-inspection readiness * Perform gap assessments on global procedures and drive alignment across site functions * Coordinate cross-functional activities and ensure effective communication with all departments * Support internal, external, and mock audit preparation, including document review and QA input * Act as backroom/ACC or scribe team member during audits and inspections * Serve as Data Integrity Champion and ensure consistent DI implementation across the site * Prepare and present compliance topics to the Quality Council and site leadership * Support continuous improvement initiatives and coordinate operational activities within the compliance team * Act as back-up for the Quality Compliance & Systems Expert when required Profile * University degree in biochemistry, chemistry, engineering, or another relevant scientific/technical discipline * Solid experience in biotechnology and/or pharmaceutical industry * Strong knowledge of GMP requirements and Quality Systems * Understanding of manufacturing, QC laboratory, and warehouse processes for biological products * Solid knowledge of Good Documentation Practices (GDDP) and Data Integrity principles * Experience supporting audits and regulatory inspections * Skilled in writing, reviewing, and updating SOPs and technical documentation * Familiarity with risk management tools (FMEA, RCA, etc.) * Proficiency in French and English (minimum B2) * Experience with eQMS tools (e.g., Veeva Vault, TrackWise), Microsoft Office, SharePoint, and Power BI Benefits * A very renowned company * Continuous support during the assignment * Individual all-round care: Support throughout the entire application phase