ACCORDING TO YOUR NEEDS, BEYOND YOUR EXPECTATION

As a member of the board of directors she is responsible for the financial activities and the strategic long and short term direction of the company. She holds a diploma in business economics. Prior to founding KVALITO, she has managed strategic, multi-national projects in the pharmaceutical industry, spanning for more than 100 countries, with an investment in excess of millions of dollars. Within these projects, she had responsibility for Quality, Risk, and Compliance across the regulated environment, including 21CFR Part 11 and Annex 11 compliance, and audit readiness. In addition to her professional experience as lecturer and coach, she has in-depth knowledge of, inter alia, validation principles, software development best practices, and quality management systems used in an FDA/EMA regulated environment.

Magdalena Kurpierz

Anne has over 7 years of work experience in the life science industry within various positions, above all with Quality Management and its nearby areas of CSV, GMP and GDP. While working in Washington, DC for Roche Diagnostics, Anne was also able to extend her knowledge in the areas of Regulatory Affairs and Market Access. Anne’s role at KVALITO as Life Science Consultant & Manager is to advise clients (previously: Boehringer-Ingelheim, Fresenius, Roche) on compliance with current GMP standards with a current focus on Data Integrity (audit preparation), while managing a team of consultants in Germany. To ensure regulatory and legal compliance are adhered to, it is necessary to regularly monitor the developments within the extensive pharmaceutical legislation and its guidelines which is also part of Anne’s responsibilities. She also has a background as trainer for CSV/ GAMP5 and Data Integrity on an international level (Germany, Spain & Poland) as part of a global SAP roll-out for a major Pharmaceutical company as well as experience in GxP Risk Assessment & Management. Furthermore, Anne is responsible for launching the KVALITO business in Spain, based in the dynamic city of Barcelona. Anne holds a B.A. from the Mannheim Cooperative State University in International Business and is currently pursuing her MBA degree at ESEI Business School Barcelona.

Anne Woitzik

Mark Kavanagh is a graduate in Electronics from the Dublin Institute of Technology. He received his Engineering Management MSc from Brunel University, London and worked for two decades with a multinational pharmaceutical company, working in Engineering and IT roles in Dublin and Paris, before moving to a Global Director role to transform the business IT Services. He joined KVALITO Ireland Ltd. in 2015 as a Life Science Consultant before taking the position as Ireland Director. As a Life Science Consultant and Director of KVALITO Ireland Ltd., Mark is focusing on growing the business in Ireland and developing the local capabilities to offer our life science clients the services they need to meet their business goals.

Mark Kavanagh

Lara Bartlett holds a degree in Law and Anthropology from the University of Keele, in the U.K. and has gained strong experience in private practice in London's magic circle firms, U.S. firms in London and Geneva, as well as in the pharmaceutical and agricultural industries in Basel. Lara has worked in commercial contracts, trademark protection, software copyright/anti-piracy, corporate and regulatory fields to support the legal function. Lara supports KVALITO employees with employment contracts Social security, migration and related issues, and reviews/drafts SOPS and company manuals.

Lara Bartlett

Florian Schnettelker holds a Bachelor of Science in Business Informatics. He studied Business Informatics at the Cooperative State University of Baden-Wurttemberg. Prior to joining KVALITO in 2014, he worked as Drug Safety IT-Specialist for a large Swiss based pharmaceutical company. He has worked on various business-critical and international projects in the GxP and non-GxP Environment. He is familiar with using Lean Management in a GxP Environment and the overlaps between GxP, IT-Security and Data Privacy. He is a Member of the ISACA German Chapter GxP-Group and works on different projects to align the IT-World with the GxP-World e.g.: GAMP5 and COBIT 5 mapping. Certified Cyber Security Practitioner.

Florian Schnettelker

Anna-Lena has over 4 years’ experience as a Life Science professional and as a research associate (PhD student) in management of data integrity, research projects, analysing data, teaching students, giving scientific talks, writing scientific publications, working independently as well as part of a team. She has practical experience in Regulatory Affairs of in vitro diagnostics (IVD) and Quality Management, EN ISO 9001, EN ISO 13485, IVDR (98/79/EC), technical documentation, SOPs, registration of IVD products. Anna-Lena has received professional training in Quality Management, Audit, GMP, CAPA Management, Process Management, Project Management. She has working experience in the pharma industry on Data Integrity including Data Mapping, Gap Assessment, Risk Analysis, interviewing production personnel, suggesting of respective CAPAs by applying ALCOA principle, based on FDA Data Integrity Guidelines, cGMP. Anna-Lena has an open-minded personality with excellent communication skills and intercultural competence. She provides management, coordination and execution of 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. She can contribute to the development of efficient and FDA-compliant Data Integrity solution to meet project / regulatory requirements within aggressive deadline. Anna-Lena can also provide harmonization of documents and alignment with project work streams (equipment, computer systems, lab processes) to ensure global implementation approach

Anna-Lena Hurter

Leo has spent the past 35 years gaining in depth experience working internationally. He has worked as a Project Quality Manager with ICE Silver certification in Pharma IGM GxP Projects (including GAAP , GAMP, V model and SDLC ). He is a Business Excellence Leader (Lean Six Sigma) in Automotive, Finance, IT, Production, Telecommunications, Pharmaceuticals and FMCG. Leo has contributed to the transformation of companies processes according to customers’ requirements, managing various global projects with direct impact on P&L. Leo has provided leadership of Business Project Management Office with over 100 project leaders. He has introduced Crisis Management and Business Continuity Plan to several companies. Leo has executed Turnkey Telecom Projects including Mobile Network Backbone Microwave and solar power systems; Testing and Validating Computer Systems (CSV) and integrating into live network. He has also setup and provided management of local regional offices in several countries on different projects Leos Personal values & skills are: Integrity • Always focused on the customer • Excellent business acumen combining strong operating process skills with entrepreneurial mind-set • Strong people leadership able to energize and inspire teams around a clear, simple and exciting vision • Smart strategic and analytical problem solving skills • Global player who enjoys leading change. Leo is fluent in Dutch, English, German, Basic Czech and improving!

Leo Bally

Elizabeth Brown is a graduate from Shannon College of Hotel Management and has a wealth of experience in sales in the hospitality, and other industries both in Europe and internationally. She has lectured in Sales, marketing and business practices and has successfully run outbound and field sales teams. Elizabeth joined KVALITO Ireland Ltd in 2017 and is working to grow the business both in Ireland and globally. She works with clients to understand their specific requirements to ensure KVALITO provides the best resources to allow the client to achieve their goals.

Elizabeth Brown

Akbar Mustafa is a Supply Chain and Operations Leader successful in the design, implementation, and management of critical supply chain and operations strategies in the communications, life science, industrial supply and wholesale industries. He is a proven Change Leader with the reputation for assessing and developing top-tier talent for dynamic and complex organizations. Akbar is also recognized for achievements in all functional aspects of program management, e-commerce, procurement, inventory planning, and sales. A profit driven, top-performer offering outstanding credentials in defining and achieving corporate and client objectives through strategic planning, continuous improvement, cost savings, risk management and profitability goals.

Akbar Mustafa

Jessica Hauswirth

Jessica Hauswirth

Over 20 years’ experience in IT and 12 years in Operations of IT Infrastructure of large Outsourcing companies with governance models based on standards and methodologies. Extensive expertise in ITIL Service Life Cycle Management (Strategy, Design, Transition, Operation and Continual Improvement) assuring good quality of deliverables in IT Critical Mission Operations for Banks, Electronic Means of Payment companies, Airlines, Industries and Insurance Health companies. As Life Science Consultant, I coach and follow-up with IT and business Management, Supervisors and Associates based on GxP and relevant regulations standards as GAMP5, EMA, FDA, ANVISA, helping to identify gaps in current processes and determine the best corrective action, ensuring continuous improvement initiatives are being executed according to plan in order to certify that IT Development will deliver the best solution for business.

Elerton Muezel

Chewbacca