Data operations manager állások, munkák minőségbiztosítás kategóriában

• Start Date: asap
• Latest Start: February 2026
• Planned Duration: 9-month maternity cover
• Extension: possible
• Location: Basel
• Workload: 100%
• Home Office: 2 days/week after 2-3 months onboarding
• Travel: none
• Team Size: 6 people
• Template Used: CH_Real World Data Scientist_LSW_CHF_RCM_CO

• Responsible for the functionality, data quality, compliance, and user-friendliness of RIMS and eCTD systems.
• Ensuring the operation, maintenance and further development of the systems (Extedo eCTDmanager, Veeva RIM).

• Conducting routine analyses for release and stability studies of antibodies, proteins and peptides using various separation techniques (e.g. SEC, IEX, RP)
• Reviewing HPLC raw data to ensure quality standards are met.
• Taking responsibility for analytical instruments

The independent analyses of secondary data, including insurance claims, electronic medical record, patient survey, and disease registry....

• Perform release and stability testing of antibodies, proteins, and peptides using capillary electrophoresis techniques (e.g. CE-SDS, cIEF, CZE) in a GMP-compliant laboratory
• Conduct analytical method validations
• Document all work accurately in LIMS, Chromeleon and on paper

• A degree in Public Health, Epidemiology, Outcomes Research, Health Economics or a related scientific field; MSc or PhD in Epidemiology preferred
• Minimum 2 years of hands-on experience with Real World Data, non-interventional study design and analysis

• Start Date:or
• Latest Possible Start:
• Duration: 6 months initially; extension possible (e.g., additional 6 months)
• Location: Basel
• Workload: 100%
• Home Office: Yes
• Travel: Not expected
• Team Size: PCS safety team approx. 6; cross-functional project teamsmembers
• Hiring Manager: Simone Melega

Continuous Improvement Leadership - Lead and champion continuous improvement initiatives using operational excellence methodologies such as DMAIC and PDCA....

Following up on production-related nonconformities, supporting root cause analyses, defining and monitoring corrective actions, and preparing evaluations and statistics of nonconformities...

Subject-Matter Expert (SME) for Test Method Development of delivery devices and combination products: Test Method development, including best practices for universal implementation, Test Method Validation/Transfer....

• Collect data and prepare progress reports, KPIs, and metrics for regional and global reporting, including monthly reports, management reviews, and quarterly quality reports.
• Support ad hoc global quality reporting by gathering data and providing contextual insights to regional QA Senior Management.

• Responsible for processing incoming complaints in accordance with applicable process specifications
• Independent processing and assessment of complex or critical complaint cases with potentially high risk to patient safety or regulatory compliance

as part of DFG sponsored project beginning in January 2026 limited for three years. The Title of the project is: EFFECTS OF LACTOBACILLUS REUTERI DSM 17938 ON THE ACUTE PSYCHOLOGICAL, ENDOCRINE AND IMMUNOLOGICAL STRESS RESPONSE IN HEALTHY CITY DWELLERS. Both preclinical and clinical data support...

• Design, develop, and optimize coagulation diagnostic assays and reagents
• Lead feasibility studies, verification, and validation activities in compliance with ISOand IVDR requirements
• Document all activities according to quality system procedures and design control standards

Prepare, support the creation and review and execute the release of all technical documentation for digital health and software products ensuring compliance with applicable standards and regulatory requirements such as IEC, IEC...