Senior Quality Operations Lead – Biotech Manufacturing

Incyte

Yverdon-les-Bains

On-site

CHF 110,000 - 160,000

Full time

14 days+

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Job summary

Incyte is seeking a Quality Operations professional to oversee the quality aspects of monoclonal antibody manufacturing at our Yverdon-les-Bains facility in Switzerland. The role covers all manufacturing departments and demands strong collaboration with Bioplant functions to ensure compliant, on-time supply of products.

The candidate will review batch records, SOPs, deviations, and CAPA plans, while promoting cGMP adherence and continuous improvement across the operation.

Qualifications

  • Academic degree in natural or applied sciences (Pharmacy, chemistry, Biotechnology, engineering).
  • Minimum 3 years of Quality Operations experience in pharmaceuticals at manufacturing sites.
  • Thorough knowledge of cGMP and international regulatory requirements.
  • Experience with biotech processes and dealing with international inspections.
  • Strong analytical and problem-solving capabilities.
  • Fluent in French (written and spoken) and good English level.

Responsibilities

  • Oversee day-to-day quality oversight of USP/DSP manufacturing and related processes on the floor.
  • Review and approve Batch Records, Master Batch Records, and deviations.
  • Ensure cGMP compliance and documentation management; support CAPA plans.
  • Foster compliance, right-first-time operations, and risk assessments.
  • Act as QA representative in manufacturing meetings and ensure collaboration with stakeholders.

Skills

Analytical skills
Problem solving
Verbal communication
Written communication
Compliance oriented
French language
English language
Auditing

Education

Bachelor's degree in Pharmacy, Chemistry, Biotechnology or Engineering

Job description

Incyte is seeking a Quality Operations professional to oversee the quality aspects of monoclonal antibody manufacturing at our Yverdon-les-Bains facility in Switzerland. The role covers all manufacturing departments and demands strong collaboration with Bioplant functions to ensure compliant, on-time supply of products.

The candidate will review batch records, SOPs, deviations, and CAPA plans, while promoting cGMP adherence and continuous improvement across the operation.

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