Anke Zampich - QA-GxP Consultant for Clinical Trials

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Leverkusen, Germany

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Experience

Jan 2010 - Present

16 years 9 months

On-site

Consultant

QA-System - QA-GxP Consulting

GCP audits: ATMPs
Phase I–IV study audits
Quality assurance in Biocell products
System audits and on-site audits
Quality assurance interim management
Vendor qualification audits
Document audits
Mock audits and for cause audits
GCP inspection readiness
Mock inspection audits
Inspection coordination/management and preventative actions
SOP development, review and training
GVP audits
GCP training
Medical devices
VICH consulting: supporting study management and VICH audits

Oct 2002 - Dec 2009

7 years 3 months

Neumarkt in der Oberpfalz, Germany

Clinical Auditor/GCP Manager

Bionorica AG

SOP training and in-house GCP training
Advice in clinical trials
Proof of inspections readiness – GCP (Clinical Research)
Proof of inspections readiness – PV (Pharmacovigilance)
Organization and conducting of internal and external system and study audits
Implementation of study management system (Pharmacovigilance)
SOP development and review

Jul 1996 - Sep 2002

6 years 3 months

Neumarkt in der Oberpfalz, Germany

Clinical Monitor (CRA)

Bionorica AG

SOP training
Assistant project management
Clinical trials phase III–IV
SOP development

Apr 1995 - Jun 1996

1 year 3 months

Neumarkt in der Oberpfalz, Germany

Pharmaceutical Representative (Medical Practitioner and Pharmacy)

Bionorica AG

Industry experience

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

Experienced in Pharmaceutical and Biotechnology.

Pharmaceutical

Biotechnology

Business area experience

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

Experienced in Quality Assurance, Research and Development, Project Management, and Sales.

Quality Assurance

Research and Development

Project Management

Sales

Summary

Experienced QA System Consultant with over 25 years of expertise in GxP-regulated environments (GCP / GVP), including clinical trial phases I–IV, global quality management, SOP development, and regulatory inspections. Specialized in quality assurance for both human and veterinary medicine, as well as medical devices.

Skills

Ms Word
Excel
Power Point
Ms Project
Ms Access
Endnote 6

Languages

German

Native

English

Advanced

Certifications & licenses

Pharmacovigilance Audits

Inspections of clinical trials by federal authorities, EMEA, FDA

Standard Operating Procedures

12th amendment to the German Medicines Act (AMG)

FDA Inspections of Clinical Trials in Europe

EndNote 6

Quality Assurance in Clinical Research

Clinical Site Audits

MS ACCESS 97

Project Management in Clinical Trials

Planning and Evaluation of Clinical Trials

Source Data Verification in Clinical Trials

Statistics

Experience

Total positions 4

Experience in Pharmaceutical 31.5 y

Avg length 7 y 10 m

Longest experience 16 y 8 m

Global experience

Countries worked in 1 (Germany)

Primary country Germany

Expertise

Recent roles Consultant, Clinical Auditor/GCP Manager, Clinical Monitor (CRA)

Main industries Pharmaceutical, Biotechnology

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

Qualifications

Certifications earned 13

Profile

Member since

January 2026

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Frequently asked questions

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Anke is based in Leverkusen, Germany.

Anke speaks the following languages: German (Native), English (Advanced).

Anke has at least 31 years of experience. During this time, Anke has worked in at least 4 different roles and for 2 different companies. The average length of individual experience is 8 years and 10 months. Note that Anke may not have shared all experience and actually has more experience.

Based on recent experience, Anke would be well-suited for roles such as: Consultant, Clinical Auditor/GCP Manager, Clinical Monitor (CRA).

Anke's most recent position is Consultant at QA-System - QA-GxP Consulting.

In recent years, Anke has worked for QA-System - QA-GxP Consulting.

Anke is most experienced in industries like Pharmaceutical and Biotechnology.

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

Anke has recently worked in industries like Biotechnology and Pharmaceutical.

Anke has recently worked in business areas like Quality Assurance.

Anke has 13 certificates. Among them, these include: Pharmacovigilance Audits, Inspections of clinical trials by federal authorities, EMEA, FDA, and Standard Operating Procedures.

The availability of Anke needs to be confirmed.

Daily rate distribution

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<€480 €480-640 €640-800 €800-960 €960+

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Daily rate avg. 805 €

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Median rate 800 €

The median daily rate is the middle value of all daily rates — half of comparable freelancers charge less, half charge more. Unlike the average, it is barely affected by outliers.

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.