Schopfheim, Baden-Württemberg, Germany
Quality-driven clinical pharmacist with diversified industry experience across clinical research, quality control, and oncology data governance. Extensive exposure from clinical oncology analytics to quality assurance of treatment and medical data in regulated settings. Demonstrated team management and cross-functional coordination experience, driving quality outcomes through effective collaboration and oversight. Project Co-Lead for the design and implementation of an in-house oncology database supporting a Roche targeted therapy clinical trial, reinforcing robust data integrity standards. Seeking to leverage clinical expertise and quality leadership to strengthen compliance frameworks and deliver sustainable organizational impact.
• Schedule and host client audits • Participation in health authority inspections • Complete client audit responses on time • Plan and perform internal audits to detect compliance issues • Complete Quality Assurance approval of investigations • Complete initial quality review of investigations and assign to appropriate investigators • Complete other QA activities as requested to support the business • Approve CAPAs • Participation in Permanent Process Improvement (PPI) activities
• Lead Order Processing and Operational teams for IMPs and clinical trial auxiliary items, ensuring accurate, compliant, and timely execution in line with SLAs and regulatory requirements. • Drive quality and operational excellence, owning process mapping, SOP management, and compliance with GxP, GDP, GMP, and internal quality standards. • Lead investigations of deviations, complaints, and risks, conducting root cause analysis, risk assessments, and implementing corrective and preventive actions (CAPAs) across departments. • Champion continuous improvement initiatives, using KPI monitoring, trend analysis, and operational observations to enhance on-time delivery, quality, and efficiency. • Ensure data integrity and process compliance to support audits, inspections, and regulatory assessments. • Collaborate cross-functionally with QA, PPI, Production, Packaging, and Sales to proactively identify risks, implement improvements, and drive “Right First Time” standards. • Act as a key business user for system enhancements and technology implementations, supporting UAT, change management, and user adoption. • Lead team development, including onboarding, training, capability building, personnel management, and workforce planning to sustain high performance and engagement. • Oversee daily monitoring of customer orders, ensuring 100% on-time recording and accurate reporting of KPIs to senior management. • Provide strategic guidance on quality, safety, and operational compliance, and represent performance and improvement initiatives in internal and global quality forums. • Conduct on-site observations of distribution and packaging processes to identify improvement opportunities and reinforce quality-driven culture.
• Conduct and write formal investigations of process deviations from local SOPs and WIs for processing the clinical trial item distribution and packaging. • Conducting initial and final risk assessment and assisting with identifying root cause and planning appropriate corrective and preventive actions • Assist in tracking and evaluating historical data and ensure a timely closure • In addition to responding to deviations/complaints in a timely manner, the job holder will work with Department Heads and work on processes to proactively identify trends, propose improvements • Understand and drive strategies to improve quality in the operational department • Ensure compliance with relevant SOPs in collecting, analyzing and applying of information from internal and external sources to conduct risk assessments • Gather information from all necessary internal and external sources to assess the impact of the deviation on products already distributed as well as the risk to future operations • Lead and support investigations in the sales, packaging and other departments • Identify the most likely root cause(s) and determine appropriate preventive and corrective actions. • Trend analysis, analysis of investigation data on product complaints and appropriate measures and cooperation with production and quality • At least 20% of the time is spent observing the IMP distribution/packaging area in order to gather relevant information about the process • Lead quality improvement processes and drive change in the operations department • Report on data and improvements in appropriate quality forums
Coordinate all relevant activities with the Business and Laboratory Management as well as the whole team. Document all relevant information appropriately on time. Quality control and quality assurance. Perform Error analysis in case of non-conformities. Manage purification of RNA and DNA & Involved with qPCR labwork flow.
Monitor Molecular Diagnostics of SARS-CoV-2 via real time PCR (RT-PCR) under RilliBäk requirements. Extract nucleic acid via manual as well as robotic mode. Handling samples which include stages like sample collection, sample preparation. Coordinate all relevant activities with the Business and Laboratory Management as well as the whole team. Document all relevant information appropriately on time. Perform Error analysis in case of non-conformities. Manage purification of RNA and DNA & Involved with qPCR labwork flow.
1. Quality assurance of medical data summarisation 2. Quality assurance of expert recommendation summary 3. Training of new team members Skills: Project Management · Data Analysis · Pharmacovigilance · Clinical Research
Oncology case data structured summarization Expert report creation Patient support with treatment recommendation Skills: Pharmaceutical Industry · Process Improvement
Patient Calls Patient demography data collection and entry Assessment of adequate data for case processingPatient Calls Patient demography data collection and entry Assessment of adequate data for case processing Skills: Customer Relationship Management (CRM)
Assisted daily patient visit rounds in different wards. Assisted in dispensing schedule X drugs. Assisted in patient counselling. Involved in Drug Information Center (DIC) activities.