• Head of Quality Assurance and Project Lead responsible for continuous improvement of the Quality Management System.
• Responsible Person to support release procedures for finished drug products.

Key achievements
Successfully aligned and implemented a Total Quality Management System for all affiliates in Germany

• Coach Project Managers as part of Tech Transfers to increase skills in project management, change management, risk management and communication at various levels of the organization.
• Development and monitoring of project plans for Tech Transfer (sterile ophthalmology) from URS to Validation (including budgeting).

• Responsible Manager for setup and implementation of a Quality Management System including Supply Chain Management and providing guidance for Lean Manufacturing.

Key achievements
Successfully implemented a quality management system and training program from scratch

• Quality support and lead investigator responsible for root cause analysis, CAPA-management and preparation of final reports to close out FDA associated deviations in vaccine production.

• Quality Manager and Responsible Person according to Section 3 of the German Narcotic Drugs Act ("Betäubungsmittelgesetz", BtMG) for foreign trade of narcotics.

• Responsible for all GMP and GDP related activities of the company as CQO and external Qualified Person performing release of API’s according to German Health Law.
• Design and set up of a complete QC-Lab at manufacturing site, championed EU-GMP and FDA inspections for GMP application

Key achievements
Championed and led establishment of complete QMS for € 35 million Pharma-Company to comply with GMP-requirements for successful EU-GMP certification and USFDA inspections.

• QA Manager responsible for evaluation, investigation and monitoring of deviations to assure ongoing compliance with MSD Core-requirements in a human vaccine project.
• QA-Observer during Technology Transfer (Process simulation) providing guidance for sterile operations in cleanroom class A/B.

Key achievements
Set up and implementation of an optimized deviation procedure to track and follow up deviations within Quality-Systems.

• Responsible Manager for negotiation and management of Quality Assurance Agreements for Drug Substance and Drug Products manufactured by Boehringer Ingelheim as CMO.

Key achievements
Set up of a dedicated work flow and implementation of new procedures to maintain, track and align GMP related core requirements for Quality Agreements in CMO-Business.

• Review of corporate quality management system preparing a GAP analysis for the alignment of global quality standards and regulatory guidelines

• Senior Project Manager for technology transfer (inter-site). Responsible for the review of validation and transfer protocols, test plans and technical specifications.

Key achievements
Succeeded a remediation project on vendor qualification program and supported authority inspections within the program

• Led design and establishment of a complete Quality Management System including Supply Chain Management to comply with GDP-requirements for application of EU-GDP certificate.

Key achievements
Successfully implemented a quality management system and training program. Provided guidance during authority inspection resulting in successful application for EU-GDP certificate

• Head of Quality Assurance with disciplinary leadership and budgeting responsibility in a corporate remediation project for continuous improvement of Quality Management Systems.
• Interface between global headquarter (USA), local consultants (50+) and internal department heads covering all quality related activities for BLA application.

Key achievements
Restructured quality departments, implemented efficient work flows and set up of a 6 month project plan to successfully work off backlogs.

• Served as Interim Chief Quality Officer for € 120 million Parallel Import Pharma Company.
• Restructured manufacturing and quality departments including reorganization of core process flows and supply chain management.

Key achievements
Created new QM-System for the manufacturing of finished products (medicinal products and FPP’s including cytostatics) and challenged renewal of manufacturing license as CQO in a management remediation project.

• Lead and achieved technology transfer to set up a new contract manufacturer for an active ingredient on behalf of a German customer.

Key achievements
Established optimized manufacturing work flow and supply chain management for industrial production with initial sales volume of € 15 million in the European market and championed increase of space-time-yields of the manufacturing process by > 20%.

• Restructured operational departments and improved supply chain management of US$ 32 million veterinary pharma company.

Key achievements
Implemented improved work flows that resulted in a 30% headcount reduction.