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Ricarda Mayer

Consultant Quality Management

Ricarda Mayer
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Munich, Germany

Experience

May 2025 - Present
11 months
Munich, Germany

Consultant Quality Management

Quality for Life Sciences (Consulting)

Expertise details
Position Summary
Consultant Quality Management at Quality for Life Sciences (Consulting)
Industries
Biotechnology
Pharmaceutical
Business Areas
Quality Assurance
  • Quality assurance / management
  • Process optimization (laboratory processes, QM/QS processes, etc.)
  • Revision and adaptation of existing systems (e.g. document management, equipment management) to ensure compliance with new regulatory requirements
  • Implementation/optimization of deviation and/or change control management processes
  • GLP and GMP support
  • Interim Quality Manager
  • QA management
  • Audits and inspections
  • Conducting internal audits / self-inspections (GLP, GMP)
  • Organization, preparation, coordination and support of regulatory inspections including creation of action plans if needed
  • Creation and revision of controlled documents (SOPs, qualification documents, manufacturing instructions, checklists, forms, etc.)
  • Content review of existing controlled documents for compliance, structure/format and consistency
  • "Streamlining" of document management systems
  • Basic training (GLP, GMP)
  • Refresher training (GLP, GMP)
  • Equipment qualifications
  • Other topics on request
Apr 2012 - Mar 2024
12 years
Munich, Germany

Compliance Senior Manager

Amgen Research (Munich) GmbH

Expertise details
Position Summary
Compliance Senior Manager at Amgen Research (Munich) GmbH
Industries
Biotechnology
Pharmaceutical
Business Areas
Quality Assurance
  • Personnel responsibility for two employees
  • Responsibility for all regulatory compliance issues at local and global levels
  • Deputy for QA in the area of GLP and GCP at the site
  • Organization, coordination and lead oversight of regulatory inspections
  • Creation, maintenance and management of the qualification and validation master plan, including support and organization of equipment management (equipment qualification and CSV)
  • Responsible for deviation and change control management
  • Creation and review of controlled documents
  • Development and delivery of GxP-relevant training
  • Implementation of the qualification and validation program
  • Harmonization of existing and new global QA processes
Dec 2011 - Mar 2012
4 months
Munich, Germany

Associate Director, QA

Micromet AG

Expertise details
Position Summary
Associate Director, QA at Micromet AG
Industries
Biotechnology
Business Areas
Project Management
Quality Assurance
  • Personnel responsibility for one employee
  • Responsible for GMP QA and deputy for GLP QA
  • Organization, coordination and lead oversight of audits and inspections by authorities and external customers
  • Review of batch manufacturing documents in collaboration with CMC and the Qualified Person, as well as organization and management of the release process for clinical material
  • Consulting and support for equipment qualifications
  • Processing, maintenance and monitoring of the deviation and change control system
  • Creation and review of controlled documents
  • Conducting GxP and QA-related training
  • Conducting internal and supplier audits
  • Project lead for ceasing GMP activities at the site, including return of manufacturing license and GMP certificate
  • Implementation of new QA processes as part of the harmonization "Amgen Inc. - Amgen Research (Munich) GmbH"
Jan 2011 - Nov 2011
11 months
Munich, Germany

Manager QA GMP

Micromet AG

Expertise details
Position Summary
Manager QA GMP at Micromet AG
Industries
Biotechnology
Pharmaceutical
Business Areas
Quality Assurance
  • Personnel responsibility for one employee
  • Responsible for GMP QA and deputy for GLP QA
  • Organization, coordination and lead oversight of audits and inspections by authorities and external customers
  • Review of batch manufacturing documents in collaboration with CMC and the Qualified Person, as well as organization and management of the release process for clinical material
  • Consulting and support for equipment qualifications
  • Processing, maintenance and monitoring of the deviation and change control system
  • Creation and review of controlled documents
  • Conducting GxP and QA-related training
  • Conducting internal and supplier audits
Nov 2008 - Dec 2010
2 years 2 months
Munich, Germany

Manager QA

Medigene AG

Expertise details
Position Summary
Manager QA at Medigene AG
Industries
Biotechnology
Pharmaceutical
Business Areas
Quality Assurance
  • Review of batch manufacturing documents for drug release by the Qualified Person according to the AMWHV
  • Point of contact for questions and implementation of GMP and quality-related measures
  • Oversight of equipment qualification activities and review of qualification documents
  • Management of technical changes to qualified systems ("Technical Change Control")
  • Processing of regulatory changes in coordination with the Regulatory Affairs department
  • Handling deviations
  • Creation and review of controlled documents
  • Conducting QA and GMP training for employees
  • Organization and execution of self-inspections
  • Introduction of trend analysis for manufacturing and analytical quality
  • Conceptual redesign of the DMS
Jan 2008 - Oct 2008
10 months
Munich, Germany

Manager QA (Head of QA Department)

IDEA AG

Expertise details
Position Summary
Manager QA (Head of QA Department) at IDEA AG
Business Areas
Quality Assurance
Apr 2007 - Dec 2007
9 months
Munich, Germany

Associate Manager QA

IDEA AG

Expertise details
Position Summary
Associate Manager QA at IDEA AG
Industries
Information Technology
Business Areas
Quality Assurance
Nov 2004 - Mar 2007
2 years 5 months
Munich, Germany

Research Associate QA

IDEA AG

Expertise details
Position Summary
Research Associate QA at IDEA AG
Business Areas
Quality Assurance
Research and Development
Apr 2004 - Oct 2004
7 months
Munich, Germany

Assistant of Head of QA

IDEA AG

Expertise details
Position Summary
Assistant of Head of QA at IDEA AG
Business Areas
Quality Assurance
Oct 2003 - Mar 2004
6 months
Munich, Germany

Working Student

IDEA AG

Expertise details
Position Summary
Working Student at IDEA AG
Industries
Information Technology

Industry Experience

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

Experienced in Biotechnology, Pharmaceutical, and Information Technology.

Biotechnology
Pharmaceutical
Information Technology
Profile match chart

Business Area Experience

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

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

Quality Assurance
Research and Development
Project Management
Profile match chart

Summary

As an experienced certified quality manager in the pharmaceutical environment, I have excellent quality awareness and understanding, as well as strong organizational skills. Proactive communication, empathetic leadership and a strategic focus allow me to lead teams in a goal-oriented and inclusive way.

By clearly prioritizing projects, managing resources efficiently and planning ahead, I meet the company's time and objectives.

My career has been shaped by successfully organizing, coordinating and overseeing regulatory inspections and customer audits.

Skills

  • Quality Assurance / Management
  • Process Optimization (Laboratory Processes, Qm/qs Processes, Etc.)
  • Revision And Adaptation Of Existing Systems (E.g. Document Management, Equipment Management) To Ensure Compliance With New Regulatory Requirements
  • Implementation/optimization Of Deviation And/or Change Control Management Processes
  • Glp And Gmp Support
  • Interim Quality Manager
  • Qa Management
  • Conducting Internal Audits / Self-inspections (Glp, Gmp)
  • Organization, Preparation, Coordination And Support Of Regulatory Inspections Including Creation Of Action Plans If Needed
  • Creation And Revision Of Controlled Documents (Sops, Qualification Documents, Manufacturing Instructions, Checklists, Forms, Etc.)
  • Content Review Of Existing Controlled Documents For Compliance, Structure/format And Consistency
  • "Streamlining" Of Document Management Systems
  • Basic Training (Glp, Gmp)
  • Refresher Training (Glp, Gmp)
  • Equipment Qualifications
  • Other Topics On Request

Hard Skills

  • Change Control Management And Deviation Management
  • Project Management
  • Design And Management Of Qualification/validation Programs

Soft Skills

  • Agile And Entrepreneurial Mindset
  • Appreciative Leadership
  • Strong Team Spirit
  • Conflict Management And Mediation

It Knowledge

  • Ms Office
  • Iwork
  • Dms Veeva Vault (Cloud-based)
  • Elpro Monitoring System
  • Chatgpt, Perplexity, Mistral
  • Sap

Languages

German
Native
English
Advanced

Education

Mar 1999 - Feb 2004

Fachhochschule Weihenstephan

Biotechnology · Freising, Germany

Nov 1994 - Feb 1999

Ludwig-Maximilians-Universität

Chemistry · Munich, Germany

Sep 1985 - Jul 1994

Luitpold-Gymnasium

High School Diploma · Munich, Germany

Certifications & licenses

Six Sigma Green Belt

Q-Learning

Lean Master

Q-Learning

Custom GPTs: Creating your own GPTs for QM

DGQ

Using generative AI in QM

MQ GmbH

Quality @Generative AI

Mehr.Wert Qualitätslösungen

ISO 13485:2016 - Introduction and implementation

TÜV

ISO 14001 – Environmental management systems

TÜV

DGQ Quality Auditor

DGQ Quality Manager

DGQ Quality Representative and Internal Auditor

DGQ

Statistics

Experience

Total positions 10
Experience in Biotechnology 16 y
Avg length 2 y 1 m
Longest experience 11 y 11 m

Global Experience

Countries worked in 1 (Germany)
Primary country Germany

Expertise

Recent roles Consultant Quality Management, Compliance Senior Manager, Associate Director, QA
Main industries Biotechnology, Pharmaceutical, Information Technology
Main business areas Quality Assurance, Research and Development, Project Management

Qualifications

Certifications earned 10

Profile

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Ricarda based?

Ricarda is based in Munich, Germany.

What languages does Ricarda speak?

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

How many years of experience does Ricarda have?

Ricarda has at least 21 years of experience. During this time, Ricarda has worked in at least 10 different roles and for 5 different companies. The average length of individual experience is 2 years and 2 months. Note that Ricarda may not have shared all experience and actually has more experience.

What roles would Ricarda be best suited for?

Based on recent experience, Ricarda would be well-suited for roles such as: Consultant Quality Management, Compliance Senior Manager, Associate Director, QA.

What is Ricarda's latest experience?

Ricarda's most recent position is Consultant Quality Management at Quality for Life Sciences (Consulting).

What companies has Ricarda worked for in recent years?

In recent years, Ricarda has worked for Quality for Life Sciences (Consulting) and Amgen Research (Munich) GmbH.

Which industries is Ricarda most experienced in?

Ricarda is most experienced in industries like Biotechnology, Pharmaceutical, and Information Technology.

Which business areas is Ricarda most experienced in?

Ricarda is most experienced in business areas like Quality Assurance, Research and Development, and Project Management.

Which industries has Ricarda worked in recently?

Ricarda has recently worked in industries like Biotechnology and Pharmaceutical.

Which business areas has Ricarda worked in recently?

Ricarda has recently worked in business areas like Quality Assurance.

What is Ricarda's education?

Ricarda attended Fachhochschule Weihenstephan for Biotechnology.

Does Ricarda have any certificates?

Ricarda has 10 certificates. Among them, these include: Six Sigma Green Belt, Lean Master, and Custom GPTs: Creating your own GPTs for QM.

What is the availability of Ricarda?

Ricarda will be available from May 2026.

What is the rate of Ricarda?

Ricarda's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.

How to hire Ricarda?

To hire Ricarda, click the Meet button on the profile to request a meeting and discuss your project needs.

Average rates for similar positions

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Market avg: 832-992 €
The rates shown represent the typical market range for freelancers in this position based on recent contracts on our platform.
Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.