Senior QA Oversight Lead Monoclonal Biologics Manufacturing

Incyte Corporation; Yverdon-les-Bains; On-site; CHF 110,000 - 160,000; Full time

Job summary

Incyte Corporation is seeking a Quality Operations professional to provide day-to-day quality oversight for USP/DSP manufacturing at the Yverdon-les-Bains facility in Switzerland. You will review batch records, SOPs, and deviations, ensuring cGMP compliance and efficient processes.

You will lead CAPA initiatives, manage documentation, and partner with manufacturing and QA to drive continuous improvement and timely issue resolution. Fluency in French and English is required.

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
• Understanding of biotech processes
• Experience dealing with international inspections
• Strong analytical and problem-solving skills
• Good verbal and written communication skills with structured communication
• Compliance-focused
• Internal auditor qualification is an asset
• Fluent in French (written and spoken) and English proficiency

Responsibilities

• Manage day-to-day quality oversight of USP/DSP manufacturing, including on-the-floor presence
• Perform Batch Record reviews and recommend disposition
• Review and approve manufacturing SOPs for efficiency and regulatory compliance
• Ensure compliance of manufacturing activities with cGMPs and procedures
• Manage manufacturing documentation (logbooks, batch records)
• Review and approve Master Batch Records and deviations/investigations
• Recommend and track CAPA plans and timely implementation
• Ensure material traceability and production change control
• Contribute to risk assessments and continuous improvement initiatives
• Conduct GMP/GEMBA tours and document actions
• Represent QA in manufacturing operations meetings
• Promote right-first-time operations and proactive issue prevention
• Foster understanding and application of GMP across BioPlant staff
• Collaborate with internal stakeholders for efficient collaboration
• Interpret GMP/regulatory requirements and implement where applicable
• Adhere to company policies and safety requirements
• Stay current with applicable regulations and promote quality across Incyte
• Support a culture of business integrity and ethics
• Act in compliance with legal requirements and company guidelines

Skills

Quality Operations

cGMP knowledge

Regulatory understanding

Analytical skills

Communication skills

French language proficiency

English language proficiency

Internal auditor qualification

Education

Bachelor or higher in natural or applied sciences

Job description

Incyte Corporation is seeking a Quality Operations professional to provide day-to-day quality oversight for USP/DSP manufacturing at the Yverdon-les-Bains facility in Switzerland. You will review batch records, SOPs, and deviations, ensuring cGMP compliance and efficient processes.

You will lead CAPA initiatives, manage documentation, and partner with manufacturing and QA to drive continuous improvement and timely issue resolution. Fluency in French and English is required.