Marcel Pieles - CAPA and Deviation Manager Pharma

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Karlsruhe, Germany

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Experience

Apr 2025 - Nov 2025

8 months

Germany

CAPA/Deviation/OOS Manager Solid Production

Haupt Pharma Wülfing GmbH – Member of the Aenova Group

Independent handling of deviations
Independent handling of CAPAs
Analysis of production OOS – assessment and closure
Technical advice in the Operations area
Complete revision of the CPV SOP, plan, report
Development of coaching materials for production employees

Aug 2024 - Dec 2024

5 months

Germany

Head of Manufacturing Solid Production

Miolma Consulting GmbH

Management of manufacturing in accordance with AMWHV and the EU GMP Guide
Preparation and training on SOPs, MBRs and other GMP/ISO-relevant documentation
Ensuring and reviewing correct batch documentation and other quality records (e.g. risk analyses)
Preparation/approval of manufacturing instructions and manufacturing documents
Implementation of CAPA measures resulting from deviations, customer complaints and audits
Analysis and interpretation of process data and continuous process improvement
Responsible for personnel planning, equipment, customer support and achieving the department's financial targets
Ensuring successful approval by European authorities and customers
Know-how holder for the responsible quality processes
Advising on the validation of manufacturing processes
Representing the area of responsibility to customers and authorities

Feb 2024 - Jul 2024

6 months

Germany

Head of Manufacturing Sterile Production

Klosterfrau Berlin GmbH

Management of sterile production in accordance with AMWHV and the EU GMP Guide
Advising production to ensure GMP-compliant manufacturing
Assessment of deviation reports
Preparation/approval of manufacturing instructions and manufacturing documents
Conducting training and preparing GMP guidelines for production
Analysis and interpretation of process data and continuous process improvement
Coordinating assigned employees to ensure the quality of manufactured products
Ensuring successful approval by European authorities and customers
Know-how holder for the responsible quality processes
Advising on the validation of manufacturing processes

Sep 2023 - Jan 2024

5 months

Germany

Head of Manufacturing ODF

Gen-Plus GmbH & Co. KG

Ensuring the timely planning, production and monitoring of manufacturing activities in accordance with AMG, AMWHV and the EU GMP Guide
Preparation and training on SOPs, MBRs and other GMP/ISO-relevant documentation
Ensuring and reviewing correct batch documentation and other quality records (e.g. risk analyses)
Initiation, implementation and management of manufacturing-related projects
Supporting and handling internal and external complaints and deviations
Implementation of CAPA measures resulting from deviations, customer complaints and audits
Approval and monitoring of changes in the change control process
Qualification of machines and premises as well as validation of processes
Responsible for personnel planning, equipment, customer support and achieving the department's financial targets
Representing the area of responsibility to customers and authorities
Responsibility for planning, implementing, monitoring and optimizing occupational safety, health and environmental protection processes

Apr 2023 - Aug 2023

5 months

Germany

Project Manager Process Optimization Packaging/Product Launch BtM

Develco Pharma GmbH

Optimization of production processes in packaging to ensure the timely product launch
Revision of the planning concept to optimize line utilization
Improvement of the packaging training system
Conducting procurement activities
Resource and budget planning
Responsibility for the entire operational planning, implementation, management and execution of BtM launch projects
Setting objectives and preparing project plans
Tracking timelines internally and externally
Conducting project meetings
Reporting to the Steering Committee

Apr 2021 - Mar 2023

2 years

Germany

Tech Transfer Manager OEB 4/OEB 5/Project Manager

R-Pharm Germany GmbH

Preparation of process risk analyses and site-by-site analysis for product transfer in the interdisciplinary project team
Preparation of transfer protocols and reports, including the definition of Design of Experiments (DoE)
Support of tech trials, verification batches and validation batches
Evaluation and documentation of results
Planning and scheduling of trials and ensuring machine capacity
Planning and coordination of material requirements and workforce deployment
Training employees on transfer activities
Operational planning, implementation, management and execution of OEB 4/5 tech transfer projects
Budget planning
Setting objectives and preparing project plans
Tracking timelines internally and externally
Conducting project meetings
Reporting to the Steering Committee

Nov 2020 - Feb 2021

4 months

Germany

Production Coordinator

R-Biopharm AG

Production coordination and process improvement for SARS-CoV-2 test systems
Increasing efficiency by streamlining production processes and increasing employee flexibility
Revision of manufacturing instructions
Technical and disciplinary management of 32 production employees
Resource and budget planning
Introduction of two semi-automatic filling lines to increase production and revision of the material flow

Oct 2019 - Present

7 years 2 months

Head of Production, Project Management, Tech Transfer Management, CAPA Manager and Process Optimization

Self-employed Consultant, Interim Manager

Oct 2019 - Sep 2020

1 year

Spain

Interim Head of Production

Hanna Healthcare S.L.

Scale-up of a new API for pellets using the bottom-spray process from development scale to commercial batch size
Optimization of the spraying process to reduce yield losses by defining spray parameters
Preparation of the validation plan and execution of process validation
Preparation of manufacturing instructions
Training operators on the new spraying process
Resource and budget planning
Technical and disciplinary management of 14 production employees
Procurement activities
Development and implementation of a new zoning concept for material and personnel flow due to Covid-19

Oct 2017 - Sep 2019

2 years

Switzerland

Head of Production

Konapharma AG

Increased production efficiency by 30% by streamlining processes and increasing employee flexibility
Reduced manufacturing costs by 15% by improving planning and control processes
Optimized product transfers and ensured on-time product launches
Reduced production deviations by 45% by revising manufacturing instructions and improving the training system
Reduced absenteeism by 30% by increasing employee motivation
Increased occupational safety through regular inspections with colleagues from other departments
Procurement activities
Technical and disciplinary management of 36 production employees
Preparation and execution of internal and external audits, reducing findings by 25%
Resource and budget planning

Jan 2009 - Sep 2017

8 years 9 months

Germany

Deputy Head of Production

Hennig Arzneimittel GmbH & Co. KG

Deputy head of manufacturing with personnel responsibility for 28 employees
Ensuring compliance with quality, delivery, and cost requirements
Improving occupational safety
Preparing and conducting internal and external audits
Participating in quality circles
Approving and ensuring compliance with manufacturing instructions and SOPs
Training employees
Planning and controlling production processes
Optimizing production processes
Conducting product transfers

Sep 2007 - Dec 2008

1 year 4 months

Germany

R&D Engineer

Losan Pharma GmbH

Developing stick pack formulations
Evaluating and co-developing a test device for checking the seal integrity of primary packaging/stick packs in cooperation with Nolek SE
Conducting, evaluating, and documenting trials for the development of innovative solid dosage forms
Conducting scale-up trials
Performing equipment qualification
Administrative tasks

Industry experience

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

Experienced in Pharmaceutical, Biotechnology, and Manufacturing.

Pharmaceutical

Biotechnology

Manufacturing

Business area experience

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

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

Quality Assurance

Production

Project Management

Operations

Product Development

Procurement

Languages

German

Native

Spanish

Elementary

Education

Oct 2003 - Aug 2007

Fachhochschule Albstadt-Sigmaringen

Diplom Ingenieur (FH) · Pharmaceutical Engineering · Albstadt, Germany

Sep 2000 - Jul 2003

Pfizer GmbH Arzneimittelwerk Gödecke

Pharmaceutical Technician · Freiburg im Breisgau, Germany

Statistics

Experience

Total positions 12

Experience in Pharmaceutical 19 y

Avg length 2 y

Longest experience 8 y 8 m

Global experience

Countries worked in 3 (Germany, Spain, Switzerland)

Primary country Germany

Expertise

Recent roles CAPA/Deviation/OOS Manager Solid Production, Head of Manufacturing Solid Production, Head of Manufacturing Sterile Production

Main industries Pharmaceutical, Biotechnology, Manufacturing

Main business areas Quality Assurance, Production, Project Management

Qualifications

Highest degree Bachelor

Member since

October 2025

Last update

October 2026

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Frequently asked questions

Have questions? Find more information here.

Marcel is based in Karlsruhe, Germany and can operate in on-site, hybrid, and remote work models.

Marcel speaks the following languages: German (Native), Spanish (Elementary).

Marcel has at least 19 years of experience. During this time, Marcel has worked in at least 12 different roles and for 12 different companies. The average length of individual experience is 2 years and 7 months. Note that Marcel may not have shared all experience and actually has more experience.

Based on recent experience, Marcel would be well-suited for roles such as: CAPA/Deviation/OOS Manager Solid Production, Head of Manufacturing Solid Production, Head of Manufacturing Sterile Production.

Marcel's most recent position is CAPA/Deviation/OOS Manager Solid Production at Haupt Pharma Wülfing GmbH – Member of the Aenova Group.

In recent years, Marcel has worked for Haupt Pharma Wülfing GmbH – Member of the Aenova Group, Miolma Consulting GmbH, Klosterfrau Berlin GmbH, Gen-Plus GmbH & Co. KG, and Develco Pharma GmbH.

Marcel is most experienced in industries like Pharmaceutical, Biotechnology, and Manufacturing.

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

Marcel has recently worked in industries like Pharmaceutical, Biotechnology, and Manufacturing.

Marcel has recently worked in business areas like Quality Assurance, Production, and Project Management.

Marcel holds a Bachelor in Pharmaceutical Engineering from Fachhochschule Albstadt-Sigmaringen.

The availability of Marcel needs to be confirmed.

Daily rate distribution

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<€480 €640-720 €800-880 €880+

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Average rates for similar positions

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Daily rate avg. 809 €

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Median rate 840 €

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 6 Nov 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.