You will identify compliance gaps, guide investigations, and lead improvements that support reliable laboratory processes. You will also share your expertise and help teams prepare for regulatory inspections. Lead improvement projects with QC, Quality
Responsible for supporting the development, coordination, and execution of cutting-edge, effective, and efficient real world evidence strategy for drug and enablement projects at global level or for key critical markets. He/she works in close partnership
As the key figure overseeing product quality and harmonisation of our Quality Management System, you will play a pivotal role in ensuring our manufacturing processes meet the highest standards. Reporting directly to the Senior Director of Quality and
Responsible for leading non‑clinical and early clinical pharmacology strategy across drug development programs. Provides expertise in PK/PD, modeling & simulation, and Model‑Informed Drug Development (MIDD) to support dose selection, study design, and
The role will be responsible for proposing and executing the global medical strategy, driving evidence generation, scientific engagement, and cross-functional collaboration throughout the product lifecycle. S/he will work closely with global stakeholders
Develop bioanalytical (especially LC/MS/MS) methods for the discovery and development of NCEs (New Chemical Entities) or NBEs (New Biological Entities). Operate and maintain LC-MS/MS instrumentation, ensuring proper calibration, troubleshooting, and
Design and deliver clinical performance study strategy, protocols, and reports for IVDR and CDx programs. Define and address clinical evidence requirements, providing clinical input into product risk evaluation and study design. Partner closely with
Provide technical leadership and mentorship to a diverse team with expertise in pharmaceutical formulation, process development, scale-up, and manufacturing support for synthetics drug products. Lead, develop, and inspire a multidisciplinary Drug Product
Lead the project management efforts for Research and Development projects through design, development and taking to market of medical devices. Manage the key activities of the project and drive project tasks to ensure timely completion of project
You will act as a trusted quality and compliance advisor. You will help teams navigate complex regulatory requirements, strengthen quality processes, manage risk and continuously improve the way clinical trials are delivered. Monitor the regulatory
Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures). Supports the development of the clinical study blueprint/protocol and associated
Responsible for leading and advancing the Clinical Quality Risk Management (QRM) framework, to strengthen clinical quality governance and support clinical program-level risk oversight. The role ensures that risk-based quality management principles are
Drive biomarker testing strategies across multiple clinical trial programs as well as diagnostic and companion diagnostic (CDx) initiatives; Act as a scientific expert in selecting fit-for-purpose analytical technologies such as LC-MS...
Provide strategic and operational leadership for the Bioanalysis and Immunoanalysis/Immunogenicity groups, ensuring alignment with Ipsen’s R&D and business objectives; Oversee the management, development, and continuous improvement of the Dreux
Contribute to the development of the audit strategy & program and plans related to the GVP area-PV processes, vendors, Partners and affiliates; Act as a GVP Audit Program Owner when delegated by Global Quality GCP/GVP Head; Perform and coordinate PV
Lead the design and computational optimisation of RNA therapeutics, particularly siRNA, integrating RNA biology with oligonucleotide chemistry to enable gene knockdown and RNA regulatory approaches, including up-regulation strategies; Define and
Actively enables compliant Research, Development and Pharmacovigilance processes (i.e., GLP GCP GVP) from candidate to asset delivery, to commercial branding, with a focus on successful global launches and sustainable access for our patients.
The ideal candidate must possess a solid foundation/expertise in Immunology with a proven track record of building cross-disciplinary teams and working cross-functionally to deliver large molecule portfolio assets to the clinic. Serve as a
You will act as the Technical Subject Matter Expert (SME) for Single-Pill Combinations (SPCs). You will be responsible for the technical oversight of manufacturing processes across internal sites and external partners (CMOs), ensuring that complex
Takes responsibility for oversight and monitoring of the system for collection, processing, reconciliation, and reporting of ICSRs for the DSE region. This includes ensuring ICSR report intake, case processing, workflow monitoring, follow-up requests,
The successful candidate will serve as Lumis' medical device regulatory subject matter expert, leading project delivery, supporting business growth, enhancing industry visibility, and further developing the Lumis brand as a recognized provider of medical
This is a highly visible, customer-facing commercial role where you will identify, develop, and secure strategic opportunities across Lonza's Integrated Biologics offering. Leveraging your industry expertise and consultative approach, you will hunt for
This role will be pivotal in ensuring all products manufactured meet the standards required for marketed drug products. They will be accountable for defining contamination control strategy and its sterility assurance practices and sever as a subject