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
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Pharmaceutical (36 years) and Chemical (3.5 years).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Quality Assurance (34.5 years), Research and Development (18 years), Project Management (7 years), Production (6 years), and Product Development (5 years).
Summary
Leverage my experience and strategic focus to lay the groundwork. My risk management expertise (published in Pharm.Ind.) and targeted analyses will help ensure teams perform effectively.
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
Profile
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