Dennis Dauscher - Business Analyst (Delivery Governance)
Experience
Business Analyst (Delivery Governance)
Merck
- Drove governance routines (scope, milestones, status/risk tracking), scope and milestone planning for a global RIM reporting initiative based on Veeva Vault RIM data; worked with a cross-functional team (Regulatory, Safety, IT, BI).
- Designed and implemented integrated dashboards (e.g., first/last batch timelines, 180-day tracking, submission vs. approval); coordinated internal IT and external partners including backlog/release planning and cutover preparation.
Business Analyst, Project Manager, Qualification Manager
Merz
- Analyzed end-to-end PV processes to identify optimization/automation potential; assessed system usage for efficiency, process breaks and existing automation features; developed improvement proposals and an OOB-focused optimization model.
- Implemented optimization concepts via targeted configuration adjustments; aligned with QA, IT and business; owned creation and execution of qualification documentation according to GxP requirements.
Business Analyst, Project Manager, Validation Manager
Merz
- Planned and steered the company-wide migration from an on-prem PV database to the cloud solution SIAB PVCM/PVR; maintained project plan/timeline (hybrid PM), moderated project/steering meetings and managed stakeholders.
- Captured and prioritized functional/technical requirements; created/aligned URS/FRS and supported the vendor; owned validation strategy and the GxP documentation set (validation concept, FMEA, test plans, final report) and steered validation activities.
Business Analyst, Management Support
Merck
- Developed a process-oriented framework to operationalize health authority expectations for ICSR (Individual Case Safety Report) reporting (E2B(R3)) aligned with ICH and local health authority requirements (e.g., FDA/EMA/PMDA).
- Specified and aligned technical requirements, supported test verification; created/maintained SOPs and delivered compliance trainings to ensure inspection-ready execution across countries.
Business Analyst, Project Manager
B. Braun
- Designed and executed a structured multi-vendor RfP (Request for Proposal) for a PV system successor; collected and analyzed proposals and consolidated results for decision-making.
- Performed supplier risk assessment and built a cost-per-case model including savings potential from automation-capable processes; derived a vendor recommendation based on functional, economic and compliance requirements in a regulated environment.
Independent Senior Consultant & Project Manager
de Gouvea Dauscher GbR
- Program delivery in regulated Life Sciences environments across Quality/Regulatory/IT stakeholders; from requirements to rollout preparation and stabilization.
- Process optimization and qualification support in validated environments; training/compliance enablement where required.
Validation Support
AbbVie
- Created validation documentation for LIMS in an analytical environment including laboratory device software and data acquisition systems; produced URS plus functional/technical specifications, system descriptions and architecture/interface documentation.
- Developed validation plans and risk analyses aligned with regulatory requirements (GAMP 5, 21 CFR Part 11) and aligned outputs with QA, IT and business to ensure documentation quality and audit readiness.
Freelance Subcontractor
JSC Management- und Technologieberatung AG
- Project governance and delivery support in regulated transformations; stakeholder alignment, steering support and rollout stabilization.
Industry Experience
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Experienced in Professional Services, Pharmaceutical, and Healthcare.
Business Area Experience
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Experienced in Project Management, Quality Assurance, Information Technology, Business Intelligence, Finance, and Procurement.
Summary
Senior Life Sciences IT consultant delivering regulated initiatives across Pharmacovigilance, Regulatory and Quality. Strong in bridging business, QA and IT from requirements and process optimization to implementation governance, qualification deliverables and rollout preparation. Experienced in global stakeholder environments, vendor selection (RfP) and management-ready steering and reporting.
Skills
Delivery Leadership In Regulated Environments: Stakeholder Alignment (Business/qa/it), Project Governance, Steering Committee And Management Reporting, Vendor Coordination, And Rollout Preparation.
Requirements Excellence: Workshops, User Stories, Functional Requirements/specifications (Frs) And Mvp Definition.
Process Optimization And Qualification: Oob-focused Improvement Concepts, Configuration Changes And Gxp Qualification Documentation/execution.
Business Analysis And Requirements: Workshops, User Stories, Frs, Mvp Definition, Workflow Baseline.
Delivery And Governance: Scope/milestones, Backlog/release Planning, Steering Support, Cutover Preparation, Stakeholder Alignment.
Gxp / Csv: Qualification Documentation And Execution, Validation Planning, Risk Assessments (Incl. Fmea), Test Planning And Summary Reporting (Gamp 5, 21 Cfr Part 11).
Training, Compliance And Enablement: Training Delivery And Adoption Support, Compliance Enablement In Validated Environments.
Domain And Solutions: Pv Systems (Pvcm/pvr), Rim Reporting (Veeva Vault Rim), Migration Planning And Controlled Execution.
Vendor Selection: Multi-vendor Rfp, Supplier Risk Assessment, Cost-per-case Modelling, Decision Recommendation.
Project Management And Collaboration: Ms Office, Ms Project, Visio, Jira, Servicenow, Hp Alm.
Pv And Regulatory Systems: Veeva Vault Rim, Arisglobal (Lsmv, Lsreporter), Feith Systems (Orbit), Rxlogix (Siab).
Languages
Education
University of Potsdam
PhD in Natural Sciences (magna cum laude) · Potsdam, Germany
University of Potsdam
Diploma in Biochemistry · Biochemistry · Potsdam, Germany
Certifications & licenses
Validation of Computerized Systems
Concept Heidelberg
Statistics
Experience
Expertise
Qualifications
Profile
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