Klaus (Dr.) Finneiser
Freelancer
Experience
Freelancer
3P Quality Consulting
Data integrity training (basic and advanced training content)
Root cause analysis and CAPA courses for 40+ employees
Risk-Management system design for quality oversight
SOP writing excellence, including use of AI tools (prompting)
Implementation of an audit remediation program as person in the plant (PIP)
Director of a quality assurance department (6 direct reports), budgeting
Development of use cases for ChatGPT in GxP context (6 months, part-time)
Reengineering of processes for a MA holder of generic products, valued operational improvements (Germany, Spain)
eQMS and document management system: delivery of the business case and investment recommendation
Analytical method validation, process and computer system validations, batch record review, PQR reviews
Articles in international journals and LinkedIn on modular QMS-design, risk-management in the supply chain, knowledge management, use of AI for compliance improvements
Head Quality System and Strategy
ACINO Pharma AG
- Completed implementation project of the corporate quality management system (ICH Q10), including quality manual and 45+ quality directives and their processes
- Set up regional offices Q-systems and communication policy with the headquarter, including restart of GCP QA and pharmacovigilance systems; led remediation program of the PV-QMS system
- Led workshop to define business needs for Trackwise redesign; communicated with IT experts to achieve results
Senior Project Manager Manufacturing Compliance
Ferring International Center S.A.
- Implemented new FDA validation concept with QbD and product lifecycle background
- Defined 50+ QA processes and aligned them with stakeholders
- Redesigned deviation and CAPA processes; improved IT tools (Trackwise)
- Set up training program to establish Certified Lead Investigators at 7 sites worldwide
Senior Quality Expert
Novartis Pharma AG
- Led SAP data integrity project in a line function
Project Manager Global Quality Improvement Projects
Novartis Vaccines & Diagnostics AG
- Managed QA compliance improvement projects in Holly Springs, North Carolina, USA and Ankleshwar, India
- Achieved substantial compliance and performance improvements: reduced lead time by 50%; increased right-first-time rate from 60% to 95%
- Reduced complaint handling throughput time by 80% worldwide as a certified six-sigma black belt
Staff Position Global Quality Management Pharma
Novartis Pharma AG
- Developed risk-based quality assurance program for legacy products (Qualimetrics)
- Served as delegate in EFPIA working groups on ICH Q9 and IPEC Europe
- Led reorganisation of the stability center in Locarno as part of project for Head Global Quality Operations
- Collaborated with country managers to maintain quality oversight, QA compliance, performance and service levels
- Managed global quality agreements (100+), set up centralized system with manufacturing sites and country organisations; negotiated with multiple CMO partners
- Owned Global Complaint Recording System (GCRS) lifecycle; provided CPO support and training for 100+ users
Global Quality Operations Product Management
Novartis Pharma AG
Project Manager Re-engineering Projects
Novartis Pharma AG
Head of Follow-up Stability Testing (QC/QA)
Novartis Pharma AG
Head of Analytical Development and Production Control
Ciba-Geigy AG
Head of Laboratory: Analytical Support for Development Projects
Henkel KGaA
Skills
Freelance & Consulting Projects (Up To 6 Months) - Quality Improvements.
Leadership Roles In Qms Design, Quality Management & Cross-functional Collaboration.
Operations And Business Process Re-engineering, Gxp Enhancement Projects, Risk Management.
Excellent Gxp And Compliance Proficiency (Certified Gmp Auditor), Experiences Over Years In Diverse Multinational Contexts. Proactive Leader, Passionate And Strategic Acumen, And Strict Result Orientation - Many Improvement Projects With Successful Completion.
Good, Cross-functional Communicator With A Holistic Mindset.
Calm In Dynamic Environments, Displaying A Natural Affinity For Embracing Change, Driving Improvements, And Adeptly Navigating Through Complex Challenges.
Languages
Education
Ph.D., 15N-NMR-Spectroscopy · 15N-NMR-Spectroscopy
University Siegen
Diploma in Chemistry · Chemistry · Siegen, Germany
University Hagen
Diploma in Organization and Planning, IT (Business Informatics) · Business administration · Hagen, Germany
Certifications & licenses
Cleanroom Expert
Auditor Certification (PCS)
ASQ Certified CAPA Lead Investigator
6-Sigma Black-Belt
Certified GMP Auditor
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