Global QA Compliance & Regulatory Lead

Incyte; Yverdon-les-Bains; Vor Ort; CHF 120.000 - 145.000; Vollzeit

Zusammenfassung

Incyte is seeking a QA Regulatory and Compliance professional for our BioPlant site in Yverdon-les-Bains, Switzerland. The role leads QA oversight of regulatory affairs activities and supports geographic expansion while ensuring compliance with global regulatory requirements.

Responsibilities include coordinating QA reviews for regulatory submissions, supporting inspection readiness, and mitigating risks for new markets.

Qualifikationen

• Master degree in Pharmacy, Chemistry, Biology or Bioengineering.
• At least 5 years in quality assurance within a biopharmaceutical manufacturing environment.
• Strong knowledge of cGMP and global regulatory requirements.
• Experience with regulatory filing processes and health authorities inspections.
• Proficiency with electronic quality systems.
• Fluent in English and French.

Aufgaben

• Ensure compliance with GMP and GDP regulations and guidelines.
• Provide QA oversight on regulatory submissions and variations management.
• Support inspection readiness and respond to Health Authority findings.
• Coordinate QA review and approval of regulatory dossier sections for BioPlant.
• Identify and mitigate risks for new markets from a QA perspective.

Kenntnisse

Quality Assurance

Regulatory Affairs

GMP/GDP knowledge

Attention to detail

Ausbildung

Master's degree in Life Sciences

Tools

Electronic Quality Systems

Jobbeschreibung

Incyte is seeking a QA Regulatory and Compliance professional for our BioPlant site in Yverdon-les-Bains, Switzerland. The role leads QA oversight of regulatory affairs activities and supports geographic expansion while ensuring compliance with global regulatory requirements.

Responsibilities include coordinating QA reviews for regulatory submissions, supporting inspection readiness, and mitigating risks for new markets.