Be the compliance catalyst ensuring alignment, audit readiness, and continuous improvement across the Neuchâtel quality organization.
Proclinical is seeking a Quality Compliance Specialist to join the Quality organization at a facility in Neuchâtel. This role focuses on GMP self-inspection activities, data integrity, and quality project deployment. You will collaborate across departments to ensure compliance with internal standards and regulatory expectations while promoting continuous improvement initiatives.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Manage and improve the GMP self-inspection system, including planning, execution, and supporting lead auditors.
- Deliver coaching sessions to SMEs and audit teams for inspection readiness.
- Define and implement risk-based self-inspection schedules in collaboration with site leadership.
- Perform gap assessments on new or revised global procedures.
- Coordinate with various departments to ensure alignment and communication.
- Benchmark best practices within the broader Biologics network.
- Support GMP audits by reviewing documents and providing QA input.
- Act as a backroom ACC team member or scribe during audits.
- Prepare and present compliance-related topics at the Quality Council.
- Serve as the local data integrity champion, ensuring adherence to principles through collaboration with global teams.
- Provide compliance support to partners and act as a backup for the Head of Quality Compliance and Systems when needed.
Key Skills and Requirements:
- University degree in a technical or scientific discipline (e.g., biochemistry, chemistry, engineering).
- Strong knowledge of GMP environments and Good Data and Documentation Practices (GDDP).
- Familiarity with manufacturing, laboratory testing, and warehousing operations for biological products.
- Experience creating, reviewing, and revising SOPs and technical documents.
- Proficiency in French and English (minimum B2 level).
- Proficiency in electronic quality management systems (e.g., Veeva Vault, TrackWise) and Microsoft Office tools.
- Knowledge of risk management tools and methodologies (e.g., FMEA, root cause analysis).
- Experience supporting regulatory inspections and audits.
If you are having difficulty in applying or if you have any questions, please contact Molly Colclough at m.colclough@proclinical.com.
Apply Now:
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