Cologne Bonn Region
Hands on Quality & Transformation Leader with 17+ experiance in highly regulated industrial environments (Pharma, Medical device, Biotec, Food & Cosmetic). Passionate about building trust & motivation in cross-functional teams to steer toward reliable results, executing short-, mid-, and long-term actions with a clear focus on the target.. Proven track record in driving efficient problem solving, Quality and Operational transformations while improving Quality & EBITDA with First time right approach, ensuring regulatory excellence (EU GMP, FDA, MDR) and implementing trustfull organizations. • Extensive experience in Quality Assurance, GxP compliance and regulatory environments within the pharmaceutical industry • Proven track record of leading large-scale change and transformation projects • Strong strategic leadership capabilities with the ability to inspire and guide cross-functional teams across global and site-specific functions • In-depth knowledge of GMP, QMS, and GxP regulations as well as experience with Change Management processes • Exceptional problem-solving and analytical skills with the ability to manage complex projects and drive data-driven decision-making • Excellent communication and interpersonal skills, also being able to collaborate effectively with stakeholders at all levels • A hands-on approach combined with the ability to navigate strategic challenges in a dynamic and fast-paced environment
Global Senior Director Quality & Transformation Defining the stategy and heading global projects to drive Quality, operational excellence, regulatory compliance, and bottom-line profitability. • Quality & Regulatory Leadership: Directing global QA, QC, and RA operations. Ensuring compliance across highly regulated markets (FDA, MDR, GMP) and comprehensive ISO frameworks (9001, 13485, 15378, 22000 45000). • Operational Excellence: Serving as Lean Leader to translate process efficiency into measurable impact. Systematically reducing cycle times and complaint rates (CCR) while driving continuous growth in OTIF, First-Time-Right, OEE, cNPS, and EBITDA. • Business Transformation: Leading the global "Transformation Offensive" and owning the Business Process Management (BPM) system. Driving the harmonization, standardization, and digitalization of core processes (R&D, Operations, Complaint Management).
Head of Quality | QMR | PRRC (MDR) Directing end-to-end global quality and regulatory compliance across 7 international sites (US & Germany) for a 4,500-employee organization. • Regulatory Authority & Governance: Serving as Quality Management Representative (QMR) and PRRC (MDR). Ensuring uncompromising compliance across complex regulatory frameworks, maintaining GMP, MDSAP, MDR, ISO-13485, and ISO-9001 certifications. • End-to-End Process Ownership: Leading global Risk Management and Quality Management. Safeguarding the complete product lifecycle (R&D, Production, QC, Distribution) for a highly diverse, high-tech portfolio: ATMPs (cell-based), pharmaceuticals, medical devices, software, and semiconductor components. • Multinational Site Leadership: Driving quality excellence and operational standardization across critical development and manufacturing hubs in the US (Boston, Gaithersburg, Auburn, Santa Barbara*) and Germany (Bergisch Gladbach, Cologne, Teterow).
Quality Management ISO:13485 / GMP MDSAP Certified Production of: Medical Device ATMPs Drugs Instruments Reagents Disposables Software Sites: Teterow Bergisch Gladbach
Head of production for Stemcell Products CD34 CD45 FACS AMWHV GMP FDA