Senior Quality Expert

Quality professional with over 25 years in Life Sciences, excelling in biopharma quality programs and continuous process improvements

Proven leader and skilled communicator, adept at mentoring teams for professional growth and organizational success in biopharma

Qualified Person under Directive 2001/83/EC, providing regulatory compliance support and conducting third-party audits as an APIC certified auditor

Extensive experience in CMO management, strategic analysis, and quality management systems, ensuring compliance with EU, FDA, and SFDA regulations

Already placed by K-Recruiting several times with great customer feedback

Ensuring vaccine products manufactured in compliance with Annex 1 and cGMP requirements. Responsible for bridging strategic quality planning with operational execution to guarantee timely product release

Restructured Quality Organization and implemented lean operational excellence

Guided establishment and execution of local quality remediation program

Responsible for establishing a corporate global GxP Quality Management System to harmonize quality operations across the internal network from preclinical development to commercial manufacturing

Developed a global GxP framework supporting quality governance across international operations

Standardized quality processes across the global manufacturing and development network

Established and led the Global Clinical Operations Quality Assurance organization responsible for quality oversight of investigational product manufacturing and supply

Built and implemented the global Clinical Operations QA function

Ensured GxP compliant manufacturing and supply across global clinical development programs

Quality lead for the COVID-19 vaccine program in China, Hong Kong, Macau and Taiwan

Oversee quality activities as part of the Joint and Corporate Steering Committees

Provide guidance and ensure technology transfer activities and business partner quality activities are conducted in accordance with global quality guidelines

Successfully implemented quality processes across the Chinese CMO network to ensure EU GMP compliant manufacturing

Establish and lead the Product Quality Complaints System for the global launch of the COVID-19 vaccine to ensure compliant handling of PQC’s in the market

Successfully established a complaint management system and procedures right in time for the global launch of the Covid-19 vaccine

Supported technology transfer programs for sterile products through project leadership coaching

Implemented structured project monitoring and budgeting procedures

Strengthened risk management and cross functional communication processes

Led quality assurance operations and quality system improvements during a corporate remediation program

Implemented a new GDP compliant quality management system across German subsidiaries

Strengthened regulatory compliance and operational quality standards

Responsible for implementing companywide quality systems and optimizing production operations

Implemented Total Quality Management framework and training program

Introduced lean manufacturing guidelines and supply chain improvements

Supported technology transfer for Ebola vaccine production and implemented harmonized quality processes

Established streamlined issue management processes for human and animal vaccine programs