About me
25+ Years in Pharma & Biotech - Now Available for Your Project.
I'm Bernhard Antes – pharmaceutical Quality professional, GMP/GDP Lead Auditor and consultant with more than 25 years of hands-on experience in regulated environments.
My background spans Quality Systems, audits and inspections, eQMS and CSV, digitalization, process improvement and international Quality projects.
Today, I make this experience available to pharmaceutical, biotech and life-science organizations that need experienced support without adding permanent headcount.
I've Spent My Career Inside the Industry
I didn't start my career as a consultant.
I spent more than 25 years working inside pharmaceutical and biotechnology organizations – experiencing first-hand how Quality Systems, regulatory requirements, projects and operational realities need to come together.
My career has taken me from laboratory and Quality Control roles to biotechnology start-ups and senior Quality leadership in an international pharmaceutical organization.
That background shapes the way I work today:
Practical. Risk-based. Compliant. And focused on solutions that actually work.
From the Laboratory to Quality Leadership
BAXTER
Laboratory & Quality Control
My pharmaceutical career began in laboratory and Quality Control roles at Baxter, providing an operational foundation in pharmaceutical manufacturing and Quality.
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IGENEON
Laboratory & Quality Control
At igeneon, I worked in the development and production of monoclonal antibodies before moving into Quality Control responsibilities.
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F-STAR
Laboratory, Quality Management & Founder
As part of the founding team of f-star, I took on responsibilities across Development, Quality Management and Operations in an innovative biotechnology environment.
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VALNEVA
Head of Quality Systems · Lead Auditor · Global eQMS System Owner
My responsibilities expanded to the management and continuous improvement of Quality Systems in an international pharmaceutical environment – including audits and inspections, digital Quality Systems and cross-functional Quality initiatives.
Quality From More Than One Perspective
Over the course of my career, I have experienced Quality from many different perspectives:
Laboratory & QC
Understanding operations where data and Quality originate.
Quality Management
Building and maintaining compliant systems and processes.
Auditor
Assessing organizations, suppliers and Quality Systems independently.
Inspection Host
Preparing organizations and supporting regulatory and customer inspections.
System Owner
Taking responsibility for digital Quality Systems throughout their lifecycle.
Quality Leader
Balancing compliance, operational reality, resources and business needs.
My Areas of Expertise
GMP/GDP & Quality Systems
SOPs · CAPA · Deviations · Change Control · Risk Management · Documentation
Audits & Mock Audits
Internal Audits · Supplier Audits · GMP/GDP Audits · Mock Audits
Inspection Readiness
Regulatory Inspections · Customer Audits · Preparation · Readiness
eQMS, CSV & Digitalization
Electronic Quality Systems · CSV · Data Integrity · Digital Workflows
Process Improvement
Quality Processes · Lean Operations · Project Support · Continuous Improvement
GxP Training
Practical Training · Quality Systems · Audits · Digital Quality
International Quality Experience
Quality Doesn't Stop at National Borders.
My work has involved international teams, suppliers, customers, authorities and system implementations across multiple countries.
As global System Owner for an electronic Quality Management System, I successfully supported implementation across:
Austria · France · Sweden · United Kingdom · United States · Canada
My professional experience also includes collaboration with authorities, auditors, customers, suppliers and software providers in an international GxP environment.
Selected Qualifications
QS/GMP Officer
Concept Heidelberg
GMP Auditor
Concept Heidelberg
GMP Lead Auditor
Concept Heidelberg
Computer Validation Officer
Concept Heidelberg
GMP/GDP – Storage & Transport
Concept Heidelberg
Cloud Computing in the GxP Environment
Concept Heidelberg
IT for non-IT experts
Concept Heidelberg
Six Sigma Yellow Belt
Step Up
Body Language
Prof. Samy Molcho
Why I Became an Independent Consultant
Making Experience Available Where It's Needed.
After more than 25 years in the pharmaceutical and biotechnology industry, I decided to make my experience available in a more flexible way.
I have seen many situations where organizations don't need another permanent employee or a large consulting engagement.
They need an experienced professional who can quickly understand the situation, work alongside the existing team and take responsibility for a clearly defined task or project.
That's the idea behind Digital Quality Compliance.
Senior expertise when you need it – whether that's for a few hours, a specific work package, an entire project or a period of increased workload.
How I Work
Hands-on
I don't stop at recommendations. Where appropriate, I support implementation and help get the work done.
Practical
Solutions need to work within your organization – not just look good on paper.
Independent
An experienced external perspective without unnecessary complexity or predetermined solutions.
Flexible
A few hours, a defined work package or a larger project – support can be adapted to what you actually need.
25+ Years of Experience. One Flexible Resource.
Whether you need an experienced second opinion, support with a specific Quality challenge or additional senior capacity for an important project – let's talk.
No additional headcount.
No long-term commitment.
Senior expertise from day one.