Quality Assurance Expert (m/f/d)

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Join the Quality Assurance Operations team at the Merck Biotech Development Center in Fenil-sur-Corsier. As a Quality 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 expertise will help create robust processes, support compliant project delivery, and drive continuous improvement in a collaborative, international environment.
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.