• Led project team to deploy LabWare LIMS at the BASF Grenzach and Lampertheim site

• Develop Data Integrity strategy and respective SOP and attachments
• Creation of templates for Data Integrity Gap Assessments, Data Integrity Risk Catalogue and Data Integrity Self-Inspection checklist for production processes
• Training of project team on Data Integrity & respective documentation
• Service Delivery as direct report to Head of Quality Management

• Project execution for different clients within the life science industry
• Team lead, training and development of consultants
• Head of Product Development Department: Built up department & respective processes; responsible for new product development (CSV, QMS, SaMD) incorporating design-thinking methodology
• Provide subject matter expertise for development and implementation of role-based data integrity and CSV training

Quality & Compliance Strategy Consultant of Digital Health Systems, Software as a Medical Device (SaMD) and Digital Health Platform

• Develop global strategy for Qualification and Validation of Digital Health Platforms used for medicinal and GxP-relevant data (PaaS, SaaS)
• CSV/ Validation Responsible during Supplier Assessment for PaaS
• Validation Lead as Project Quality Manager for Digital Health Platforms incl. formulation of VMP

• Lead the Project for the Preparation and Execution for FDA Pe-Approval Inspection for Commercial Manufacturing (DS/DP for Molecules and Antibodies) to comply with all inspectional objectives
• Conduct Pre-Inspections within Analytical Labs (GMP, GLP) and train Quality Team for PAI audit
• Evaluate and mitigate gaps for compliance of FDA PAI objectives for the new Quality System for Commercial Manufacturing, i.e. Data Integrity, Computer System Validation
• Review, update & creation of process documentation (Global and local SOPs & templates) according to FDA requirements

• Optimization of vendor management process including creation of respective documentation
• Controlling, monitoring and improving the implementation of the validation process for R&D computer systems according to GLP, GCP, GVP; specifically, development of various templates for Life Cycle documentation
• Consulting in quality management, especially in quality risk management, quality risk assessment and ad hoc quality control 

Service Delivery and direct report to Head of Quality

• Conduct Audit and Inspection Readiness for MDR in the area of Computer System Validation
• Provide strategic advice in creating a Corporate Framework within existing QMS 13485 for Computer System Validation, implementing a corporate procedure for CSV including templates for validation management
• Implementing CSV Strategy into ITIL processes within IT Department
• Formulate Validation Strategy for current IT Systems as part of the QMS, fulfilling requirements from FDA (820.20, Part 11), Annex 11 and ISO 13485, execution of all validation activities and documentation
• Develop Validation Lifecycle Documentation and Templates, i.e. Validation Plan, Test Plan, Validation Report (German and English documentation)
  

Service Delivery and direct report to Head of Quality

• Creating concept for Validation Strategy for the Re-validation of current IT Systems as part of the QMS, fulfilling requirements from FDA (820.20, Part 11), Annex 11 and ISO 13485, execution of all validation activities and documentation
• Support in strategy and advice to establish and improve a Corporate Framework within existing QMS 13485 for Computer System Validation, implementing a corporate procedure for CSV including templates for validation management

• Realization of Validation Strategy for the Development and Implementation of local and global IT Systems for Document Management (Documentum D2 for eTMF, eCTD, Submission Management, R&D) and Data Handling (eLN, Rotronic RMS) within the Research & Development Laboratory
• Providing strategy and advice to establish a Corporate Framework for Project Governance of Computer System Validation and Equipment Qualification during Laboratory Relocation

• Auditing an IT Supplier and its Cloud Solution for Clinical Trial Analytics and Data Management (SAS)
• Audit Preparation, Desktop Audit (Document Review), Onsite Audit at Data Center and Quality Department, manage audit response with Supplier
• Create Audit Plan and Report, follow up on Audit Closure

• In charge of the full range of all Project Management tasks for implementation of LIMS at Düsseldorf (Holthausen) site to ensure full reflection of user needs
• Leadership of the project team (23 team members)
• Review of validation plan, risk analysis and validation report
• Accountable that all plans reflect management expectations and keep all plans up to date
• Coordination of project team activities
• Assurance that released validation and qualification reports / conditional release documents are created and approved as pre-requisite for the Go Live

• International project execution and support for different clients within the life science industry (see following positions) for IT Quality & Compliance and Project Management
• Team lead, training and development of junior consultants
• Provide subject matter expertise for development and implementation of role-based data integrity and CSV training as required
• Development of extensive templates and guidance for lifecycle documentation

• Actelion GxP Compliance Analysis, Gap Assessment and Remediation
• Ensuring J&J Quality standards are applied to Actelion processes and documentation
• Validation of a large number of applications ? Following SDLC Application Track
• Multi-Site / Cross-functional remediation; applying J&J quality standards on Actelion processes and documentation

• Management, coordination and execution of Data Integrity Gap Assessments and Data Maps (data flow diagrams) to identify Data Integrity risks for all Drug Substance production processes in close alignment with Quality Department and definition / suggestion of respective CAPAs by applying ALCOA principle
• Development of efficient and FDA-compliant Data Integrity solution to meet project / regulatory requirements within very demanding deadline 
• Harmonization of documents and alignment with project work streams (equipment, computer systems, lab processes) to ensure global implementation approach
• Audit / client assessment preparation to achieve and maintain Data Integrity compliance within current GMP and regulatory requirements