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QA Compliance Expert (M/F/D)
Tasks:
Deliver coaching sessions to SMEs and audit teams to ensure preparedness for inspections and self-inspections.
Define and implement the self-inspection schedule using a risk-based approach; in collaboration with site leadership.
Performed gap assessments on new/revised global procedures.
Ensure communication and coordination with all departments
Collaborate with the broader Biologics network to benchmark best practices and ensure alignment across sites.
Plan and coordinate SLT Gemba
Act as the local data integrity champion
Ensure Data Integrity on site through a strong collaboration with Global Teams and other facilities.
Availability outside regular hours during audits or critical events.
Strong autonomy, rigor, communication, and cross-functional collaboration skills.
Prepare, analyze and present key topics related to the compliance activity at the Quality Council
Provides Compliance Support to Partners
Act as back-up for the Quality Compliance and Systems Expert (inspection readiness, compliance topics)
Support the preparation of GMP audits by contributing to document reviews and providing QA input in collaboration with Quality Compliance Expert.
Act as a backroom (ACC) team member, or Scribe member during audits.
Qualification:
University degree in technical/ scientific discipline such as biochemistry, chemistry, engineering or equivalent
At least 7 years of experience in the biotechnology and/or pharmaceutical industry, preferably both
Strong knowledge of a GMP environment
Good understanding of manufacturing, laboratory testing and warehousing operations applicable to biological products.
Good understanding of Good Data and Documentation Practices (GDDP) and Data Integrity principles. Experience in creating, reviewing, and revising Standard Operating Procedures (SOPs) and technical documents.
Experience supporting regulatory inspections and audits.
Familiarity with risk management tools and methodologies (e.g., FMEA, root cause analysis).
- Proficiency in French and English (minimum B2 level or equivalent).
- Proficiency in using electronic quality management (e.g., Veeva Vault, TrackWise).
- Proficiency in Microsoft Office tools, including Word, Excel, Power Point and SharePoint.
- Proficiency with data analysis and reporting tools, including Power BI.
Occasional travel may be required (e.g., to other sites for alignment or training)
Ability to access all site areas
Availability outside regular hours during audits or critical quality events.
Strong autonomy, rigor, communication, and cross-functional collaboration skills.
Requirements:
Start: 16.03.2026
Duration: 6 months
Capacity: 5 days per week
Location: Neuchatel, Switzerland
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