QA Operations Expert DS (m/f/d)

Merck; Aubonne; On-site; CHF 110,000 - 160,000; Full time

Job summary

Merck in Aubonne, Switzerland, seeks a Quality Assurance Operations Expert for Drug Substance to partner with Technical Operations and Quality Management, ensuring drug substance batches meet quality and regulatory standards.

You will own end-to-end quality oversight of manufacturing processes, apply risk-based quality decisions, review procedures, and lead CAPA programs, with responsibilities including Certificates of Conformity and Certificates of Analysis for onsite batches, plus role as

Qualifications

• University degree in Pharmacy, Biology, Chemistry, or equivalent.
• At least five years of QA experience in the pharmaceutical/biopharmaceutical industry.
• Solid GMP knowledge and ability to apply risk-based decisions.
• Experience in deviation management and CAPA implementation.
• Fluent in French and proficient in English.

Responsibilities

• Own end-to-end quality oversight of drug substance manufacturing processes.
• Review and approve manufacturing procedures and batch records; establish Certificates of Conformity and edit Certificates of Analysis.
• Act as Responsible Person Delegate for drug substances under Swiss regulations.
• Contribute to monthly quality indicator reviews and lead the Annual Quality Review for drug substances produced onsite.

Skills

QA experience

GMP knowledge

Deviation management

Root cause analysis

CAPA

French fluency

English proficiency

Cross-functional collaboration

Education

Pharmacy degree

Biology degree

Chemistry degree

Job description

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role

As a Quality Assurance OperationsExpert for Drug Substance, you will serve as a critical quality partner within the Technical Operations and Quality Management team at the Aubonne site, ensuring that drug substance batches, whether manufactured internally or externally for market, or validation purposes, meet the higheststandards of quality and regulatory compliance.

You will own the end to end quality oversight of drug substance manufacturingprocesses, applying a risk based approach to compliance, deviation management, and corrective and preventive action programs. You will review and approve manufacturing procedures and batch records, establish Certificates of Conformity, and edit Certificates of Analysis for batches produced on site. Acting as Responsible Person Delegate for drug substances in accordance with applicable Swiss regulatory requirements, you will contribute to monthly quality indicator reviews and lead the Annual Quality Review for drug substances produced on site.

Who You Are

• You hold a university degree in Pharmacy, Biology, Chemistry, or arelated scientific discipline, or bring equivalent professional experience.
• You have at least five years of experience in quality assurance within the pharmaceutical or biopharmaceutical industry.
• You bring solid knowledge of Good Manufacturing Practice requirements and health authority expectations, with the ability to apply a risk based approach to quality and compliance decisions.
• You are experienced in deviation management, root cause analysis, and the implementation of corrective and preventive action programs.
• You are fluent in French and professionally proficient in English, enabling effective collaboration across a multilingual, international environment.
• You work with a strong sense of ownership and attention to detail, and you thrive in a cross functional setting where quality, science, and operational excellence intersect.
• You communicate clearly and constructively with stakeholders at all levels, from manufacturing teams to regulatory and supply chain partners

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!