Senior QA Compliance & Regulatory Lead (GMP/GDP)

Incyte; Yverdon-les-Bains; On-site; CHF 140,000 - 170,000; Full time

Job summary

Incyte in Yverdon-les-Bains (BioPlant) seeks a QA Regulatory and Compliance lead responsible for ensuring GMP/GDP compliance, supporting regulatory submissions, and managing inspection readiness across global markets.

The role requires 5+ years in biopharma QA, a Master in a relevant field, and fluency in English and French, with strong knowledge of cGMP, regulatory filings, and quality systems.

Qualifications

• Master degree in Pharmacy, Chemistry, Biology or Bioengineering.
• Minimum of 5 years in quality assurance in a biopharmaceutical manufacturing environment.
• Thorough knowledge in cGMP and global regulatory requirements.
• Experience in Regulatory filing processes.
• Experience in international Health Authorities inspections.
• Proficiency with electronic quality systems.
• Fluent in English and French.

Responsibilities

• Ensure GMP/GDP compliance and oversee regulatory affairs-related activities.
• Support regulatory submissions and variations management with QA oversight.
• Maintain inspection readiness and lead remediation of findings.
• Collaborate with Regulatory Affairs and partner teams on regulatory dossiers.
• Identify and mitigate QA risks for new markets.

Skills

Regulatory compliance

Quality assurance

Critical thinking

Attention to detail

Project management

Education

Master's degree in Pharmacy, Chemistry, Biology or Bioengineering

Tools

Electronic quality systems

Job description

Incyte in Yverdon-les-Bains (BioPlant) seeks a QA Regulatory and Compliance lead responsible for ensuring GMP/GDP compliance, supporting regulatory submissions, and managing inspection readiness across global markets.

The role requires 5+ years in biopharma QA, a Master in a relevant field, and fluency in English and French, with strong knowledge of cGMP, regulatory filings, and quality systems.