Klaus Finneiser - Quality Systems Consultant for Pharma

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Oberwil, Switzerland

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Experience

Oct 2017 - Present

9 years

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

Jun 2013 - Sep 2017

4 years 4 months

Aesch, Switzerland

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

Nov 2010 - May 2013

2 years 7 months

Saint-Prex, Switzerland

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

May 2010 - Oct 2010

6 months

Basel, Switzerland

Senior Quality Expert

Novartis Pharma AG

Led SAP data integrity project in a line function

Dec 2007 - Apr 2010

2 years 5 months

Basel, Switzerland

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

Aug 2001 - Nov 2007

6 years 4 months

Basel, Switzerland

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

Feb 2000 - Aug 2001

1 year 7 months

Global Quality Operations Product Management

Novartis Pharma AG

Oct 1998 - Feb 2000

1 year 5 months

Project Manager Re-engineering Projects

Novartis Pharma AG

Feb 1996 - Sep 1998

2 years 8 months

Head of Follow-up Stability Testing (QC/QA)

Novartis Pharma AG

Feb 1990 - Jan 1996

6 years

Basel, Switzerland

Head of Analytical Development and Production Control

Ciba-Geigy AG

Jun 1986 - Dec 1989

3 years 7 months

Düsseldorf, Germany

Head of Laboratory: Analytical Support for Development Projects

Henkel KGaA

Industry experience

See where this freelancer has spent most of their professional time.

Experienced in Pharmaceutical and Chemical.

Pharmaceutical

Chemical

Business area experience

See which departments and functions this freelancer has contributed to most.

Experienced in Quality Assurance, Research and Development, Project Management, Production, and Product Development.

Quality Assurance

Research and Development

Project Management

Production

Product Development

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

German

Native

English

Advanced

French

Intermediate

Italian

Elementary

Education

Oct 1983 - Jun 1986

Ph.D., 15N-NMR-Spectroscopy · 15N-NMR-Spectroscopy

Oct 1977 - Jun 1983

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

Certified GMP Auditor

Statistics

Experience

Total positions 11

Experience in Pharmaceutical 36.5 y

Avg length 3 y 7 m

Longest experience 8 y 11 m

Global experience

Countries worked in 2 (Switzerland, Germany)

Primary country Switzerland

Expertise

Recent roles Freelancer, Head Quality System and Strategy, Senior Project Manager Manufacturing Compliance

Main industries Pharmaceutical, Chemical

Main business areas Quality Assurance, Research and Development, Project Management

Qualifications

Highest degree Doctorate

Certifications earned 5

Profile

Member since

July 2025

Last update

January 2026

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Frequently asked questions

Have questions? Find more information here.

Klaus is based in Oberwil, Switzerland and can operate in on-site, hybrid, and remote work models.

Klaus speaks the following languages: German (Native), English (Advanced), French (Intermediate), Italian (Elementary).

Klaus has at least 40 years of experience. During this time, Klaus has worked in at least 11 different roles and for 7 different companies. The average length of individual experience is 4 years and 8 months. Note that Klaus may not have shared all experience and actually has more experience.

Based on recent experience, Klaus would be well-suited for roles such as: Freelancer, Head Quality System and Strategy, Senior Project Manager Manufacturing Compliance.

Klaus's most recent position is Freelancer at 3P Quality Consulting.

In recent years, Klaus has worked for 3P Quality Consulting.

Klaus is most experienced in industries like Pharmaceutical and Chemical.

Klaus is most experienced in business areas like Quality Assurance, Research and Development, and Project Management. Klaus also has some experience in Production and Product Development.

Klaus has recently worked in industries like Pharmaceutical.

Klaus has recently worked in business areas like Quality Assurance and Research and Development.

Klaus holds a Doctorate in 15N-NMR-Spectroscopy and a Bachelor in Business administration from University Hagen.

Klaus has 5 certificates. Among them, these include: Cleanroom Expert, Auditor Certification (PCS), and ASQ Certified CAPA Lead Investigator.

The availability of Klaus needs to be confirmed.

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Daily rate avg. 1067 €

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Median rate 940 €

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Calculated based on our freelancers’ daily rates as of 7 Sep 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.