Germany
Senior Quality & Transformation leader with a strong background in regulated industries, combining Quality Management, digital systems, and data-driven governance. I help organizations build robust, inspection-ready structures while enabling sustainable change across people, processes, and systems through lean and agile leadership principles. My experience spans GxP Quality Systems, IT-enabled transformation (eQMS, data, reporting), and leadership roles where clarity, structure, and accountability are critical. I am particularly strong in aligning stakeholders, translating complexity into actionable governance, and creating operating models that scale. Known for a pragmatic, hands-on leadership style, I focus on empowering teams, fostering ownership, and embedding a resilient quality culture that supports both compliance and business performance.
Main Responsibilities: • Acting Head of Quality Systems in a regulated GxP/radiopharmaceutical environment • Full ownership of team structure, hiring, onboarding, coaching, target & performance alignment • End-to-end ownership of Veeva Vault QMS processes (documents, training, reporting, etc.) • QRB governance, KPI reporting & management enablement up to Board level • Strategic business partner to Production, Quality Control, Engineering, QualVal, Clinical QA & IT • Cross-functional stakeholder management incl. regulatory authorities, external auditors & global quality leadership Key Projects & Achievements: • Built Quality Intelligence Dashboard (Power BI + Veeva API) from zero — rolled out across Q-Unit and operational areas; shifted oversight from reactive to data-driven • Led cross-functional Task Force that dramatically reduced overdue QMS records across Deviations, CAPAs, Changes & Periodic Reviews within weeks • Authored CSV/Automation Oversight Report as central FDA/ROB inspection reference covering ISA-95 hierarchy, traceability matrix & full system inventory • Orchestrated full FDA GMP Mock Inspection readiness for the Quality Systems department incl. SME matrix, storyline strategies and live audit response • Designed & implemented Quality Systems Strategy across strategic objectives & operational workstreams — aligned with SVP & Q-Unit Leadership • Rebuilt logbook issuance process: transferred ownership to departments while maintaining full GMP compliance & audit-trail integrity • Secured headcount approvals, filled multiple roles simultaneously & established structured onboarding concepts reducing day-one lead times • Commissioned & managed external team coaching program; introduced agile operating model (Kanban, Daily Huddles, sprint cadence) improving team accountability & throughput
Building and leading a consulting business focused on quality systems, transformation and operational excellence in regulated and complex environments — supporting organizations as a trusted advisor and interim leader across Pharma, Life Sciences and beyond. Core focus areas include: • GxP Quality Systems & inspection readiness (FDA, EMA, EU GMP) • Digital Quality & system landscapes (e.g. Veeva Vault, data & reporting architectures) • Transformation programs across quality, operations and business processes • KPI frameworks, management reporting & data-driven decision models (Power BI & beyond) • Interim leadership & organizational build-up (team design, hiring, capability development) Working closely with leadership teams and operational stakeholders to turn strategy into execution, with a strong focus on clarity, ownership and sustainable results — supported by a growing team and flexible delivery setup.
Responsibility for the strategy, governance, and IT coordination of a Quality Systems migration to Veeva QMS and QualityDocs. Engagement scope focused on defining the target migration approach, governance model, and IT coordination for transitioning Quality System content (SOPs, deviations, changes). Responsibilities included shaping the target-state concept, defining data model and mapping standards, establishing data integrity and validation principles (GxP), and aligning stakeholders and implementation partners on a scalable pilot-to-global rollout approach for a digital Quality Systems landscape.
Independent consulting role focused on senior advisory, interim leadership readiness, and selective engagements in Pharma Quality and regulated environments. Positioned as a senior sparring partner for quality leadership, governance design, and transformation initiatives, with emphasis on system-oriented thinking, inspection readiness, and sustainable operating models.
Main Responsibilities: • End-to-end quality oversight across GMP/GDP as well as GCP/PV-related processes, including deviation, change, document, risk, and learning management. • Accountable for Quality Release of finished pharmaceutical products and medical devices, including assessment of deviations, complaints, damages, and returned goods. • Development and maintenance of quality processes, procedures, and KPIs with a strong focus on management-relevant reporting and decision support. • Planning, coordination, and execution of self-inspections, external audits, and regulatory inspections involving health authorities and third-party logistics partners. Key Projects & Achievements: • Built and led a high-performing quality team (up to 5 professionals), ensuring stable daily operations for batch release, investigations, and affiliate GMP/GDP processes. • Led the local rollout of a paperless, real-time documentation solution (iPad-based) for incoming goods, including the transition from manual temperature loggers to a cloud-integrated monitoring system—significantly improving data integrity and process efficiency. • Drove the local transformation of the IT Quality Management landscape, including data preparation and mapping of SOPs and quality documents from Documentum ECM to Veeva Vault QualityDocs, and quality records from TrackWise to Veeva Vault QMS. • Appointed PMO Lead for an organizational restructuring initiative, responsible for setting up workstreams, prioritizing initiatives, and tracking execution and progress across functions.
Main Responsibilities: • Appointed as Training Site Lead with end-to-end accountability for GxP training governance, regulated learning processes, and system operations at site level. • Acted as Quality Partner to business and management, representing local training processes within global communities of practice and expert networks. • Ensured inspection-ready training compliance through clear governance, defined roles & responsibilities, and continuous alignment with GxP requirements. Key Projects & Achievements: • Led the local implementation of the Cornerstone OnDemand learning management system, including data transformation and migration from SAP Learning Solution, data cleansing and mapping, training material development, and end-user enablement for more than 120 employees through go-live and hypercare. • Conceptualized and executed a fully digital, paperless GxP training environment, establishing a scalable best-practice approach that was later adopted by multiple affiliates and entities across the company network. • Redesigned the local GxP training process and introduced a “learning on demand” model, strengthening learner accountability while enhancing management oversight and compliance transparency. • Supervised students and interns contributing to the development of GMP e-learning content, ensuring alignment with regulatory expectations and internal quality standards.
Main Responsibilities: • Ensuring data integrity within IT systems, processes, batch records, validation documentation, interfaces, and change events. • Definition and further development of the validation process for computerized systems (CSV) in the Quality Control laboratory with focus on US 21 CFR Part 11, GAMP 5, ICH, and EU GMP regulations. • Managing the lifecycle of quality documents and company agreements. Key Projects & Achievements: • Leading the IT project during a quality control lab decommissioning to ensure long-term storage, accessibility, and health authority–approved data integrity of analytical data in a virtual cloud environment. • Represented the CSV process in 10+ GMP inspections (including HA Germany, US FDA, etc.), as well as internal and external audits.