Analytical Operations and QC Compliance Specialist - All Genders -(CDM 11 months)

Duration: fixed-term contract of 11 months  

Your Role:

As the GxP Compliance Specialist in the Analytical Operations and Quality Control Department of the Biotech Development Center (BDC), you will be responsible to ensure QC processes are compliant to Good Practice (GxP) regulations and standards as well as Merck requirements. You will contribute to the continuous improvement of processes and workflows. Furthermore, you will support the team during investigations related to observations and deviations, change controls, audit preparations etc. Thus supporting our commitment to quality and excellence when delivering products for our specialty innovator Biotech pipeline.

Responsibilities:

• Support the QC team in their daily operations as an expert of compliance aspects for QC.
• Manage, investigate and close events and deviations in support of Subject Matter Experts in QC.
• Contribute to the data review process according to the established quality requirements.
• Manage and support the timely and effective completion of deviations, non-conformances, investigations, change controls, and CAPAs; perform period reviews.
• Continuously improve data integrity (DI) knowledge base, including DI risk-analysis assessments and action plans, and periodically report status/progress to leadership team.
• Author, review, approve and maintain life cycle of relevant Standard Operating Procedures, Work Instructions, and all other quality documents related to areas of responsibility, as well as support other areas as required.
• Contribute to the assessment of regulatory and pharmacopoeia updates linked to QC activities.
• Support preparation of audits and interact directly with internal HCQ auditors and external regulatory agencies.
• Recommend and drive improvements to existing systems, processes, techniques or programs.
• Manage training plans of the team and support in ensuring training compliance.
• Collaborate with cross-functional teams, in particular act as Singe Point of Contact to QA, to address compliance issues and implement corrective actions.
• Provide training and guidance to staff on GxP regulations and best practices.
• Stay updated on industry regulations and trends to ensure continuous compliance.

Who you are:

• Graduate degree in Chemistry, Pharmacy, Biology, or Biotechnology.
• Practical experience working in a in QC lab.
• Experience with Quality Systems such as Deviation, CAPA, Change control.
• Strong knowledge of GLP/GMP/Quality System requirements and international guidelines (e.g. ICH, FDA, EMA) for biopharmaceuticals; knowledge of Data generation, Data processing, Data Quality principles.
• Excellent investigational and problem-solving skills. Ability to interpret complex situations and to articulate recommendations for issue resolution.
• Previous direct experience in audits and interactions with health authorities.
• Preferred hands-on experience with laboratory information systems, digital tools, automation technologies and lean principles.
• Highly motivated, self-driven, autonomous, flexible and able to multi-task to support department and business objectives.
• Proactive in delivering results and driving improvements
• Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
• You are fluent in English (B2 or higher), French is a plus.

The position is based in Corsier-sur-Vevey in the Merck Biotech Development Center.

Department: Analytical Operations & Quality Control

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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!

Apply now and become a part of our diverse team!