2002–2003
Postdoctoral research
Development of a DNA sequencing technology based on single-molecule analysis.
VisiGen Biotechnologies, Houston, USA, in research collaboration with Heinrich Heine University Düsseldorf, Germany.
About Me
Dr. Enno Schweinberger
Over 20 years of experience in the pharmaceutical industry, with regulatory responsibilities since 2010. Independent consultancy services from 2027.
For me, quality means taking responsibility. Not as an abstract principle, but through concrete decisions that can be justified and supported by evidence.
My professional career spans research, pharmaceutical development, quality assurance and international responsibility for quality management systems. From 2027, I will make this experience available to pharmaceutical and life sciences companies as an independent consultant for selected quality and compliance assignments.
As an independent consultant, I will be your direct point of contact, personally supporting agreed assignments from initial technical assessment through to implementation.
Career
Professional experience
From 2027
Independent Consultancy
Dr. Schweinberger Quality & Compliance GmbH
Independent consultancy for selected Responsible Person (RP), quality and compliance assignments, with a focus on GMP, GDP and regulatory responsibilities.
2022–2026
Global Quality
Siegfried AG
Head Global Quality Management DS & Responsible Person (RP)
Responsible for global quality management across seven international API manufacturing sites in Europe, the USA and China.
- Responsible Person (RP) for wholesale distribution and international trading activities.
- Integration of manufacturing sites, including sites acquired from Novartis and BASF.
- Harmonisation of quality management systems (QMS) across API manufacturing sites.
- Responsibility for Quality Agreements.
- Chair of the APIC Task Force on Good Distribution Practice.
2010–2022
Quality Assurance
Siegfried AG
November 2012 – January 2022
Head Quality Assurance & Qualified Person
Led the Quality Assurance organisation in Zofingen, comprising approximately 25 employees.
September 2010 – October 2012
Head Quality Assurance & Qualified Person Drug Products
Led the Quality Assurance department for finished medicinal products, comprising four employees.
- Responsible Person (RP) for active pharmaceutical ingredients (APIs) and finished medicinal products.
- Deputy Responsible Person for controlled substances.
- Lead of the Nitrosamine Task Force.
2004–2010
Pharmaceutical Development
Siegfried AG
January 2007 – August 2010
Head Analytical Development
Led a department of approximately 15 employees.
February 2004 – December 2006
Analytical Project Manager
Established and led a working group of three employees.
Education
Academic education & research
1999–2002
PhD in biophysical chemistry
Dr. rer. nat., University of Göttingen, Germany.
Research conducted at the Max Planck Institute for Biophysical Chemistry, Göttingen.
Research focus: Multidimensional single-molecule fluorescence spectroscopy.
1996–1998
Organic Chemistry
Diplom-Chemiker (Dipl.-Chem.), University of Osnabrück, Germany.
1991–1995
Chemical Engineering & Biotechnology
Diplom-Ingenieur (FH), University of Applied Sciences Ostfriesland, Germany.
Continuing Professional Development: Ongoing professional development in GMP, GDP, Quality Risk Management and regulatory requirements.
Approach
What I stand for
Practical implementation of quality & compliance
I support pharmaceutical and life sciences companies with selected quality and compliance assignments, applying a practical, risk-based approach with a clear focus on workable solutions.
Broad experience across the pharmaceutical industry
My experience spans research and development through to commercial manufacturing, from active pharmaceutical ingredients to sterile finished medicinal products. Another key area of expertise is quality management in pharmaceutical wholesale distribution (GDP).
Direct collaboration and clear decisions
I work directly with my clients, provide clarity on complex quality-related matters and take responsibility for well-founded decisions and their implementation as an independent partner.
Transparency and sustainable results
My approach focuses on transparent collaboration, clear communication of risks and outstanding issues, and traceable results that remain effective over the long term.
Let's get to know each other
An initial consultation provides an opportunity for us to assess whether we are a good fit, both professionally and personally.