2022 ? today: Providing all required quality and regulatory affairs services
Role: Managing Director
Customer: ADHOCON UG (haftungsbeschränkt) | Ludwigshafen, Germany
- Providing all required quality and regulatory affairs services for all classes of Medical Devices and In-Vitro-Diagnostics, Software as Medical Device (SaMD) with AI based algorithms, legal manufacturer services (Contract Legal Manufacturer
- Management of all key Quality and Regulatory processes and worldwide registration and submission of Medical Devices, IVDs and SaMDs to place on market
- Due Diligence for Quality, Regulatory and Marketability aspects of partnerships and M&A operations
- Expert and Expert Witnesses for Medical Devices of all classes (EU).
- Ad-hoc Consulting via messenger services, such as WhatsApp, Signal, and Facebook.
- Accelerated business growth by providing additional services,
- Regulatory Due Diligence for M&A
- Regulatory Penetration Testing and Social Engineering training
- Business Continuity Management according to ISO22301
- QMS on demand (ISO9001 and ISO13485 for legal manufacturers and suppliers)
- EU MDR registered Authorised Representative and PRRC (EUDAMED)
2021 ? 2023: Leading global quality and regulatory department
Role: Global Director Head of Quality & Regulatory Affairs
Customer: HUMA Therapeutics Limited | London, UK
- Leading global quality and regulatory department for HUMA, permanent Member of the Huma Executive Committee
- Leading quality and regulatory department for HUMA, Software as Medical Device (SaMD), legal manufacturer of Class IIb (EU MDR), and Class II (US FDA 21CFR, 510(K)) Medical device Software solution with AI and algorithms built in, for pediatrics and adults within 307 days
- Defined and improved all key processes and headed Worldwide registration and submission of SaMD to place on Market.
- Lead all key processes and headed Worldwide registration and submission of SaMD to place on Market.
- Enablement of all Huma Departments in Quality and Regulatory ownership with 5 external audits without findings
- Key Account support and customer meetings with Top10 Pharma for a companion solution
- Performed due diligence for regulatory and quality aspects of partnerships and M&A operations, including AstraZeneca, Bayer, and Takeda, guaranteeing compliance with set standards.
- Utilised Jira and Confluence to assure compliance with ISO 13485, MDSAP, ISO 27001, CyberEssentials, and CyberEssentials+ certifications as well as HIPAA, GDPR, DSGVO compliance, ISO/IEC 62304, 62366, 82304 compliance, and ICH and GCP compliance incorporated into a lean QMS with a minimal number of forms.
- Coaching all departments in how to integrate Quality and Regulatory in own systems and processes without changing way of working (automation without secondary documentation)
2016 ? 2021: Led Quality Management Systems
Role: Senior Director Quality & Regulatory Compliance, Sales and Service Units
Customer: Getinge Group | Karlsruhe Area, Germany
- Led Quality Management Systems for entire Sales territories used for monitoring all end-to-end key processes of country.
- Contributed to achieving real-time organisational success by overseeing registration of products (Medical Devices and IVDs) in 132 countries for more than 150K SKUs, Authority Interaction (FDA, EMEA, BfArM, SFDA, NMPA (Chinese FDA) and management, corrective field actions (Recalls), complaints, non-conformity, and CAPA management, along with implementing all local and global guidelines and rules/regulations. Involved in planning and executing Active Authority Management (AAM) with BfArM, ANSM, ANVISA, Health Canada, TGA, MHRA, and US FDA while offering adequate training to technical file reviewers.
- Recognised for designing and initiating governance structure with supplier management process as a sponsor for global third-party product project.
- Improved complaint management by deploying fully validated (US FDA CFR part 11 compliant) robotic software automation.
- Played significant role in introduction and sponsor quality and regulatory Lean Six Sigma projects ? Lean Quality Management, Lean Sales Support (Q-Ticket System), and Lean Country Registration.
- Leveraged exceptional leadership skills to lead and train young leaders while acting as internal and external mentor.
- Acquired ISO9001:2015 and ISO13485:2016 certifications from Matrix while leading and supervising QRC Teams in the five EMEA sales regions (6 direct reporting at director level and 42 indirect reports) to meet desired quality standards.
- Integrated the quality management systems across all sites, acted as the EMEA EU MDR (DEKRA and TUEV SUED) implementation project leader and sponsor, and prepared the sales and service units to fulfill economic operator requirements.
2014 ? 2016: Achieved organisational goals by heading Quality Assurance and QPs
Role: Director, Head of Quality ? Chemical & Pharmaceutical Development
Customer: Merck Group | Darmstadt Area, Germany
- Achieved organisational goals by heading Quality Assurance and QPs for Clinical Development of all clinical trial phases. Developed and employed new and effective independent Quality Management System with ICH Qx, approved by US FDA during PAI with 0 Form483 deviations for pharmaceutical growth and quality improvement.
- Facilitated organisation by efficiently developing and introducing key processes that optimise time transfers from R&D to development, development to commercial production.
- Spearheaded projects and managed quality management systems for clinical trial supplies, analytics, formulation development, operations, and dossier.
- Collaborated and built productive relationships with existing and new third-parties worldwide following international regulations and standards, such as FDA cGMP, EU GMP, and ISO13485.
- Led fully outsourced projects and accomplished targeted objectives while using strong analytical abilities.
2012 ? 2014: Managing existing and new 3rd party manufacturers according international regulations
Role: External Manufacturing Quality Manager Health & Hygiene
Customer: Reckitt Benckiser Healthcare UK | Kingston upon Hull, UK
- Managing existing and new 3rd party manufacturers according international regulations and standards (FDA cGMP, EU GMP, ISO13485, ISO 22716, ISO 9001, EC Dir 93/42, EC Dir 1223 / 2009 and food supplementary) in Europe and partially asia (Japan, India, China).
- All quality aspects are managed and controlled : Raw materials, quality control, quality systems, logistics, manufacturing, documentation, release process
- Issuing with all 3rd parties technical agreements (Agreements on roles and responsibilities), Specifications, Manuals and support of commercial agreements
- Management of adverse events and consumer complaints
- Management of recalls and mock-recalls
- Reviewing and approving of all 3rd party related documentation (Specifications, SOPs, policies, Change Controls and contracts)
- Auditing critical 3rd parties and approving all 3rd party related audit reports including their suppliers
- Managing external audits by authorities (MHRA, European country authorities and notified bodies) with no major or critical observation
- Actively working with authorities and notified bodies
2011 ? 2012: Expansion and Maintenance
Role: Head of Quality
Customer: Kukident GmbH, Reckitt Benckiser Group | Weinheim, Germany
- Head of Quality, Leading Quality Control including active release, Quality Management of site as well as service providers, suppliers and 3rd party manufacturer
- Expansion and Maintenance of GMP Standards and the certification oft he site according german Medizinproduktegesetz, ISO9001, ISO 13485, ISO 22716, BRC Standard
- Control and Approval of quality standards and policies in accordance with external and internal legislation and regulations
- Ongoing development and continous Improvement of all internal quality processes
- Coordination and Approval of all quality relevant documentations within Reasearch and Development, Production, Logistics and Distribution and quality
- Review and Approval of all Specifications within Research and Development projects and ongoing life cycle management of exisiting products
- Support, Due Dilligence and post-market surveillance of new product developments
- Responsibly leading of internal and external audits and inspections
- Operational and disciplinary leading of 5 direct reports in Quality department
- Transfer of european and global changes with regards rto quality to local site Special projects accomplished :
- Member of global project team for global quality management software TrackWise, responsible for parts oft he Validation (DQ, IQ, OQ, PQ) and transfer and implementation to local site including transfer of exisiting quality documentation on site.
- Change Control Standards Management in Health & Personal Care
- Successful first time Certification of Weinheim site according cosmetic guideline and ISO 22716
- First time Qualification (DQ, lQ, OQ, PQ) and Validation of all equipments and methods (succesful implementation according Medical Device Directive)
2009 ? 2011: Headed the manufacturing
Role: Head of Manufacturing and Teamleader GMP Compliance
Customer: Warner Chilcott / Procter & Gamble Pharma | Darmstadt, Germany
- Headed the manufacturing (according cGMP FDA Regulation and German AMWHV)
- Managing manufacturing of prescrition drug ?Asacol?
- Approving all commercial and clinical trial batches
- Reviewing and approving of all manufacturing GMP documents, all qualification (DQ/IQ/OQ/PQ), validation documents as well as all Change Control procedures
- Responsible for reviewing and approving validation and qualification documentation
- Member of Supply Chain Team
- Member of Quality Pillar (Total Productive Management System)
- System Owner Deviation Management
- Preparation and lead of authority audits in production area, Self Improvement Audits and internal audits (according german law AMWHV and AMG, cGMP / FDA and EMEA)
- Preparation, review and optimisation of various key performance indeces as well as preparation and follow up of gap analysis and action plans
Teamleader GMP Compliance
- Head of team batch record review (electronic based and paper-based batch record)
- System Ownership of Trainings-System.
- Integrated planning of process- und project-related actions regarding GMP and Compliance aspects (mainly validation, qualification, manufacturing instructions, regulatory support)
- Key interface between production and quality systems, quality assurance, quality control, planning and warehouse and distribution
2005 ? 2009:
biological drug substances in preformulation and formulation
Role: Lab scientist at Pharmaceutical Development Parenterals
Customer: Abbott GmbH & Co. KG | Ludwigshafen, Germany
- CMC-responsible manager for biological drug substances in preformulation and formulation during all clinical phases, mainly phase I and II
- Process development and process optimization, particularly of freeze-drying cycles
- Production of clinical suppliy batchers in the pilot plant under aseptic GMP conditions (class A and Isolator)
- Pharmaceutical analytics of different methods e.g. NIR, DSC, mDSC, Microscopy, Z-potential, stirring stability of proteins, viscosity, density, quantification and filtration tests
- Responsible project manager for the rebuilding of a parenteral lab as well as acquisition of a new customized pilot-scale freeze-dryer
- Member of the Communication Committee