Compliance Specialist – GMP Compliance

About the role

We are seeking a Compliance Specialist to strengthen GMP compliance across Technical Services and Manufacturing Support at our Bulle site. You will work closely with Quality and operational teams to ensure high‑level compliance, support inspections and audits, and drive continuous improvement.

Key responsibilities

• Ensure Technical Services and Manufacturing Support processes, activities, and documentation comply with GMP, regulatory and internal requirements.
• Act as a compliance and documentation partner for department management, providing guidance and operational support.
• Support deviations, investigations and CAPA follow‑up in collaboration with Quality and subject‑matter experts.
• Coordinate and support internal audits and inspections, including preparation, documentation readiness and action‑plan follow‑up.
• Manage training and competence matrices, aligning roles with GMP training requirements.
• Contribute to continuous‑improvement initiatives by proposing pragmatic, compliant, value‑adding solutions.

Required profile

• Bachelor’s or Master’s degree in Life Sciences.
• Experience in a GMP‑regulated pharmaceutical or manufacturing environment.
• Solid understanding of GMP compliance, documentation management, deviations, CAPAs and audits.
• Ability to work cross‑functionally with diverse stakeholders in a regulated setting.
• Strong organizational skills with a structured, analytical approach.
• Proactive, collaborative mindset with a strong sense of ownership and accountability.
• Fluent communication skills in French and English.

Required skills

• GMP compliance
• Documentation management
• Deviation handling
• CAPA management
• Audit coordination