QA Operations Expert - Drug Substance Quality Leader

Merck Healthcare; Aubonne; On-site; CHF 120,000 - 180,000; Full time

Job summary

Merck Healthcare is seeking a Quality Assurance Operations Expert for Drug Substance at the Aubonne site. You will partner with Technical Operations and Quality Management to ensure batches meet quality and regulatory standards, overseeing risk-based quality control and CAPA processes across internal and external manufacturing.

The role requires a university degree in a scientific field, 5+ years QA experience, strong GMP knowledge, and fluency in French with professional English.

Qualifications

• Minimum 5 years of QA experience in pharma/biopharma.
• Solid knowledge of GMP requirements and health authority expectations.
• Ability to apply a risk-based approach to quality and compliance decisions.
• Experience in deviation management, root cause analysis and CAPA programs.
• Fluent French and professional English proficiency.

Responsibilities

• Own end-to-end quality oversight of drug substance manufacturing processes.
• Review and approve manufacturing procedures and batch records; establish CoC and CoA for on-site batches.
• Act as Responsible Person Delegate for drug substances per Swiss requirements.
• Contribute to monthly quality indicator reviews and lead the Annual Quality Review for drug substances produced on site.

Skills

Quality assurance

GMP knowledge

Deviation management

Root cause analysis

Stakeholder communication

Education

University degree in Pharmacy/Biology/Chemistry

Job description

Merck Healthcare is seeking a Quality Assurance Operations Expert for Drug Substance at the Aubonne site. You will partner with Technical Operations and Quality Management to ensure batches meet quality and regulatory standards, overseeing risk-based quality control and CAPA processes across internal and external manufacturing.

The role requires a university degree in a scientific field, 5+ years QA experience, strong GMP knowledge, and fluency in French with professional English.