PM/ PMO, QA, QC

5/2022 – 4/2023

Supplier and material management:
Creation of an overview of all GMP and non-GMP materials used on site
Check and verification of correct material and supplier categorization
Mapping of the legacy SOP landscape and real-life processes
Development of a risk-based system to ensure compliance of all GMP materials and GxP services
Implementation of audit findings to legacy SOPs regarding internal distribution and release
Creating six SOPs to reorganize the material and supplier selection, management, performance evaluation, material qualification, list of qualified materials and approved supplier list
Creating training materials and trained the client`s expert in the new procedures
Supporting the creation of the audit plans for 2022 and 2023 and the negotiation of new QAAs
Performing supplier audits at a subcontracted GxP service provider and a supplier of cell banks
Assessing the EP/ USP compliance of all dossier materials, to support the submission for approval by the FDA

Train the Trainer, Auditor, Good Manufacturing Practices, Prozessoptimierung, Qualitätsmanagement / QS / QA (IT), Risikomanagement, Supplier Relationship Management (SRM)

5/2022 – 8/2022

Project lead and project manager in the development of a framework and creation of a self-assessment questionnaire with different levels of difficulty to assess the digital literacy of the client`s employees
Creation of a catalog of requirements for the digital literacy questionnaire in stakeholder workshops
Development of appropriate questions with different levels of difficulty
Evaluating and revising the framework and difficulty levels in close cooperation with the client`s experts
Development of several hundred questions, including answer options and four distinct difficulty levels a data basis for the client`s newly implemented tool for self-assessment

It-Beratung, Projektleitung / Teamleitung (IT), Projektmanagement (IT)

9/2021 – 3/2022

Project lead and project manager in the assessment of the digital maturity of the IT-infrastructure and software landscape throughout all departments of the company
to give a solid basis for strategic decision-making regarding digital transformation
to increase the company´s competitiveness and help them to become more innovative
Development and creation of a framework to assess the maturity in different digital topics
Creation and implementation of an online questionnaire with over 80 questions
Deep-dive into specific topics with stakeholders of different hierarchy levels, incl. the board of directors
Collecting and evaluating the results from online questionnaire and the interviews
Comprehensive written report and presentation of as-is situation, guidance and first steps to improve

Prozessoptimierung, Good Manufacturing Practices, Projektleitung / Teamleitung (IT), Projektmanagement (IT), Risikoanalyse

1/2020 – 4/2022

Supporting the in-use qualification of several hundred materials:
Preparation of status reports and project overviews
Carrying out risk assessments for compliance evaluations
Training of stakeholders and knowledge transfer to SMEs
Conducting a series of workshops on process optimization of the qualification process for raw materials:
Development of a new control strategy
Identification and reduction of redundancies and duplicate structures
Reduction of the number of necessary documents
Support of a pilot project for intelligent supplier management
Support for the introduction of a new SAP tool for raw material management
Supporting the development of a bot to digitize and automate the process for selecting suitable raw material candidates for reduced incoming raw material testing

Train the Trainer, Good Manufacturing Practices, Prozessoptimierung, Qualitätsmanagement / QS / QA (IT), Risikoanalyse, Supplier Relationship Management (SRM)

1/2020 – 12/2020

Supporting the qualification of several hundred newly selected raw materials (chemical, biological, SUS):
Review of audit and QAA status, as well as supply history (requesting updates/ changes if necessary)
Communication with suppliers and internal stakeholders
Performing compliance and risk assessments
Analysis of supply chains to ensure reliability of supply
Training of staff and SMEs
Creation of guiding documents and job aids
Developing and implementation of tools to automate recurring tasks

Supplier Relationship Management (SRM), Qualitätsmanagement / QS / QA (IT), Prozessoptimierung, Six sigma, Good Manufacturing Practices, Risikoanalyse

9/2019 – 12/2019

Retrospective analysis of supply chains and quality gaps of raw materials (chemical, biological)
Assessment of the complexity of the supply chain
Assessment of raw material quality
Evaluation of quality and audit history (audit results, deviation, SCNs).
Evaluation of GMP and pharmacopoeia compliance
Development of risk mitigation strategies

Supplier Relationship Management (SRM), Qualitätsmanagement / QS / QA (IT), Risikomanagement, Good Manufacturing Practices, Risikoanalyse