Senior QA/QC Expert — Drug Substance Release

Incyte Corporation; Lavamünd; Hybrid; EUR 127,000 - 190,000; Full time

Job summary

Incyte Corporation in Austria is seeking a QA QC Expert to oversee Drug Substance batch testing and release, and to provide QA oversight for QC activities at the Incyte Bioplant facility. The role ensures compliance with cGMP, Swiss/EU/US FDA regulations and company policies.

You will chair disposition meetings, review QC data, approve specifications and methods, and support Health Authorities inspections. Strong technical and communication skills in English and French are essential.

Qualifications

• Bachelor’s or academic degree in a relevant field (Chemical Engineering, Bio-engineering, Bioprocessing, Pharmacy, Chemistry, Biotechnology).
• Experience in GMP environment and QA for QC topics.

Responsibilities

• Review batch disposition records for Drug Substance/product release and shipping.
• Chair weekly disposition meetings and monitor related KPIs.
• Lead QA oversight of the QC laboratory and review methods/validation.
• Support Health Authorities inspections and regulatory submissions.

Skills

Microbiology expertise

GMP experience

QA for QC topics

cGMP/cGDP knowledge

Quality systems

Regulatory knowledge

Communication skills

Cross-functional collaboration

Education

Relevant degree (Chemistry/Biotech)

Job description

Incyte Corporation in Austria is seeking a QA QC Expert to oversee Drug Substance batch testing and release, and to provide QA oversight for QC activities at the Incyte Bioplant facility. The role ensures compliance with cGMP, Swiss/EU/US FDA regulations and company policies.

You will chair disposition meetings, review QC data, approve specifications and methods, and support Health Authorities inspections. Strong technical and communication skills in English and French are essential.