Quality Assurance Expert - Expert 2

Merck; Corsier-sur-Vevey; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Merck Biotech Development Center in Fenil-sur-Corsier is seeking a Quality Assurance Expert - Operations to ensure that manufacturing activities meet health authority requirements and Merck quality standards.

You will provide QA oversight across GMP operations, partner with operational teams to ensure compliant documentation, and participate in health authority inspections and internal quality audits, contributing to a culture of quality across international teams.

Qualifikationen

• Master's degree in life sciences or related field.
• Five to seven years in pharma/biotech with GMP QA experience.
• Experience collaborating with quality professionals in development and manufacturing.
• Strong knowledge of health authority regulations and international teams.

Aufgaben

• Provide QA oversight for GMP manufacturing activities and deviations.
• Review and approve change controls and risk assessments.
• Act as local QA data manager and key user for SAP LEAN.
• Ensure documentation meets health authority expectations and Merck quality standards.
• Support health authority inspections and internal audits.

Kenntnisse

GMP QA

Leadership

English fluency

Communication

Problem-solving

Ausbildung

Master's degree in life sciences

Tools

CARA

TrackWise

MES

SAP LEAN

Jobbeschreibung

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.

Join the Quality Assurance Operations team at the Merck Biotech Development Center in Fenil-sur-Corsier. As aQuality Assurance Expert - Operations, you will help ensure that manufacturing activities and related operational processes meet applicable health authority requirements and Merck quality standards.

You will work closely with operational teams, providing practical quality oversight across GMP operational activities.

Your role:

• Maintain operational quality processes within your areas of responsibility, primarily related to deviation management, master electronic batch record review/approval, and electronic batch record review.
• Act as the local QA data manager and key user for SAP LEAN.
• Provide QA oversight for manufacturing activities, for example by participating actively in Quality on the Shopfloor.
• Partner with operational teams to ensure activities meet defined quality specifications.
• Support overall operational readiness by defining QA requirements and helping implement the required documentation.
• Participate in and approve risk assessments relevant to your area of responsibility.
• Review, approve, and follow up on deviations and change controls.
• Help ensure that BDC projects and operations remain aligned with health authority expectations and applicable Merck quality standards.
• Participate in health authority inspections and internal quality audits.
• Work with colleagues across operational units, other healthcare sites, and functional quality teams.

Your profile:

• A master's degree or equivalent in a life science or related discipline, such as pharmacy, biochemistry, chemistry, or a comparable field.
• Five to seven years of experience in a pharmaceutical or biotechnology environment.
• Demonstrated expertise in a GMP quality assurance environment.
• Broad experience collaborating with quality professionals in new product development and/or routine GMP manufacturing.
• Strong knowledge of health authority regulations and quality requirements.
• Experience working in international, multicultural teams.
• Fluency in written and spoken English.
• Knowledge of French is an advantage.
• Strong interpersonal, communication, and leadership skills.
• A proactive approach to quality, with a strong customer and results orientation.
• Excellent analytical and problem-solving abilities.A structured and organized approach to workload planning and project delivery.
• A flexible, curious, and collaborative mindset, with a willingness to learn and share knowledge.

Systems experience

Experience with relevant quality and Merck IT systems is expected. Proficiency in CARA, TrackWise, MES, and SAP LEAN is mandatory; experience with GxP Manager, GLIMS, OsiPI or comparable systems is an advantage.

What success looks like

In this role, you will be successful when you:

• Provide clear, timely, and practical QA guidance to operational teams.
• Maintain effective oversight of manufacturing activities.
• Help teams deliver compliant documentation and operational-readiness milestones.
• Make sound, evidence-based quality decisions and follow issues through to resolution.
• Build trusted relationships across functions and contribute positively to a culture of quality and continuous improvement.

About the working environment

You will be part of a collaborative Quality organization supporting the Biotech Development Center. The role offers the opportunity to work across functions, contribute to development and operational activities, and engage with colleagues in a diverse international setting.

This job description describes the general nature and level of work expected for the role. It is not intended to be an exhaustive list of all responsibilities, duties, or qualifications.

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!