5 Years+ Experience jobs in Belgium (6), Czech Republic (1), France (8), Germany (15), Greece (1), Ireland (23), Italy (9), Lithuania (1), Malta (1), Multiple Countries (16), Netherlands (12), Poland (7), Romania (2), Spain (6), Switzerland (27) and United Kingdom (23).
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
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...
Lead and develop a multidisciplinary team of process engineers, specialists, and manufacturing professionals, fostering a culture of safety, quality, accountability, and continuous improvement. Take ownership of operational performance within the DSP
Lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM; Participate in internal activities related to (external) manufacturing such as process changes, major/critical deviations, risk assessments and CAPAs;
Root cause analysis (RCA) and CAPA implementation for project topics, and general lab topic. Investigation and management of deviations, as Lead Investigator. Quality oversight and audit readiness in GMP-regulated labs (participation in audits for
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
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
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
Accountable for setting and executing the site Quality Assurance strategy, ensuring sustained cGMP compliance, regulatory readiness, and a strong quality culture across manufacturing operations. This role serves as a senior member of the site leadership
Define and execute EU regulatory strategies in alignment with global development plans. Serve as primary EU regulatory contact with EMA and coordinate interactions with National Competent Authorities. Lead preparation and execution of Scientific Advice,
You'll be a recognised expert and a key contributor to the strategic direction of Risk-Based Management across the company; including representing BMS externally with industry groups and key partners. You'll work with a significant portion of BMS's
Provision of scientific and technical leadership to multidisciplinary teams to achieve corporate goals in challenging research projects within early-stage biologics drug development. Developing, executing and optimizing protein production processes
Ensure highest quality standards are maintained in areas of responsibility and that industry best practice is adopted in accordance with current GLP, GMP and regulatory body directives; Ensure all laboratory analysis is carried out in a safe
Deliver medical-scientific training to the field force and internal business functions, including new product launches; Build relationships with Key Opinion Leaders (KOLs) and participate in conferences and hospital meetings with healthcare professionals
This is an exciting opportunity for an experienced Medical Professional looking for a new challenge in an environment where your impact is instantly visible. It is a chance to become an integral member of a small, highly motivated team tasked with
Lead and oversee all Regulatory Affairs activities across the European Union, ensuring regulatory compliance, lifecycle management, and strategic regulatory support for existing and new products. Drive regulatory strategy, manage the team
In this role, you will perform analytical method development, optimization, validation activities and stability testing supporting pharmaceutical development of drug products. You will combine strong technical expertise with scientific problem-solving and
You will provide senior statistical leadership across clinical and translational programs. This is a hands-on, high-autonomy role with strong matrix leadership: you will shape quantitative strategy, guide study design and analysis oversee complex
Accountable for leading an injectable analytical group: developing, validating methods, characterizing structures of peptides and complex injectables with state of the art techniques. Preparing technical reports to demonstrate structural and impurity
In this pivotal role, you will design and execute the innovative data strategy that underpins our clinical development pipeline, ensuring the highest standards of scientific rigor and regulatory compliance across all trials and study phases fundamental to
Leads and handles all Quality & Compliance related programs supporting manufacturing, testing and release. This includes the clinical and commercial manufacturing and testing in full compliance with all J&J and governmental environmental, health, safety,
You will lead the design and execution of the global medical strategy for highly specialized assets with significant unmet medical need. You will play a key role in shaping the clinical and scientific narrative, enabling evidence generation, and building
Manage day-to-day laboratory activities for assigned formulation projects, providing guidance and support to scientists to ensure high-quality scientific delivery. Ensure laboratory practices comply with SOPs, quality standards, IOPs, and Health & Safety
The role leads the site's independent Quality Assurance organization, accountable for an effective, risk based Quality system. The role is responsible for inspection performance/readiness activities, data integrity and accountable to ensure final batch
Responsible for leading regulatory strategies and operations to support the development, registration, and lifecycle management of Assigned Almirall’s pharmaceutical products across global markets. This role ensures regulatory compliance, drives
Lead the multidisciplinary Clinical Team at development-program level, providing scientific direction, strategic alignment and accountability across the program. Shape innovative clinical development strategies that maximize the compound's value
Responsible for leading day-to-day quality control laboratory operations and ensuring effective support for QA, Technical Service, and Production in line with site schedules and targets. This role supervises a team of QC Chemists reports to the QC
The position is responsible for leading international (non-North America) Scientific Communications within Medical Affairs, overseeing the development and delivery of high-quality scientific and medical content for approved and investigational products.
The role is responsible for ensuring Gilead’s medical affairs activities comply with pharmaceutical regulations and laws and providing expertise on drug safety and medical topics. Provides medical expert advice to ensure accuracy of data to support
Acts as a subject matter expert and escalation lead for complex quality issues, inspection readiness, and quality risk management, and ensures consistent, compliant and inspection-ready execution of quality activities across projects vendors, and systems,
In this role, you will support Servier’s research pipeline by contributing to strategic data management projects, ensuring that our preclinical data is a trustable asset for life-changing therapeutic innovation. Ensure data integrity within your