Global QA Regulatory & Compliance Lead

Incyte Corporation; Yverdon-les-Bains; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Incyte Corporation seeks a QA Regulatory and Compliance lead at our BioPlant site in Yverdon-les-Bains to strengthen global regulatory compliance and support market entry into new regions. This role oversees regulatory affairs-related QA activities and prepares for Health Authority inspections.

Key duties include ensuring GMP/GDP compliance, coordinating QA reviews of regulatory submissions, supporting regulatory filings, and driving continuous improvement of the Quality system.

Qualifikationen

• Master degree in Pharmacy, Chemistry, Biology or Bioengineering.
• Minimum 5 years in QA within biopharmaceutical manufacturing.
• Thorough knowledge of cGMP and global regulatory requirements.
• Experience in Regulatory filing processes.
• Experience in international Health Authorities inspections.
• Proficient with electronic quality systems.
• Strong analytical thinking with attention to detail.
• Excellent written and verbal communication; English and French proficiency.

Aufgaben

• Ensure GMP and GDP compliance across the site and globally.
• Provide QA oversight on regulatory submissions and variations.
• Support regulatory and geographic expansion initiatives.
• Coordinate QA review of regulatory dossier sections relevant for BioPlant.
• Prepare Annual Product Quality Review for Drug Substances campaigns.
• Support internal audits and self-inspection processes.
• Lead inspection readiness and remediation of findings.
• Escalate major compliance risks to management.

Ausbildung

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

Jobbeschreibung

Incyte Corporation seeks a QA Regulatory and Compliance lead at our BioPlant site in Yverdon-les-Bains to strengthen global regulatory compliance and support market entry into new regions. This role oversees regulatory affairs-related QA activities and prepares for Health Authority inspections.

Key duties include ensuring GMP/GDP compliance, coordinating QA reviews of regulatory submissions, supporting regulatory filings, and driving continuous improvement of the Quality system.