Frank Heinemann - Head of Quality

Q: Where is Frank based?

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

Q: What languages does Frank speak?

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

Q: How many years of experience does Frank have?

Frank has at least 39 years of experience. During this time, Frank has worked in at least 14 different roles and for 42 different companies . The average length of individual experience is 1 year and 9 months . Note that Frank may not have shared all experience and actually has more experience.

Q: What companies has Frank worked for in recent years?

In recent years, Frank has worked for Pharmaceutical Company (Big Pharma - Manufacturer) , Midsize Pharma Company (Manufacturer) , Pharma Company , Logistic Provider (3PL / 4PL) , and Pharmaceutical Companies .

Q: Which industries is Frank most experienced in?

Frank is most experienced in industries like Biotechnology , Pharmaceutical , and Information Technology . Frank also has some experience in Professional Services , Healthcare , and Education .

Q: Which business areas is Frank most experienced in?

Frank is most experienced in business areas like Quality Assurance , Project Management , and Operations . Frank also has some experience in Strategy , Research and Development , and Information Technology .

Q: Which industries has Frank worked in recently?

Frank has recently worked in industries like Biotechnology , Pharmaceutical , and Transportation .

Q: Which business areas has Frank worked in recently?

Frank has recently worked in business areas like Operations , Strategy , and Quality Assurance .

Q: Does Frank have any certificates?

Frank has 32 certificates . Among them, these include: Service Provider Qualification in the GDP Environment , GDP Update 2024 , and GDP for Active Pharmaceutical Ingredients (APIs) .

Recommended expert

Unterschleißheim, Germany

Experience

Sep 2025 - Present

8 months

Pharmaceutical Company (Big Pharma - Manufacturer)

Support of re-organization-process at GMP-QA-system
Review, adaptation and restructuring PQR-process and documentation
Review, adaptation and restructuring GMP-warehousing-process and documentation
Support / consulting of GMP-processes (deviations / complaints / others)
Review, adaptation and restructuring GMP and GDP interfaces / processes

Jun 2025 - Dec 2025

7 months

Midsize Pharma Company (Manufacturer)

Support of IT-department in different quality aspects regarding IT
Documentation of ongoing IT-infrastructure re-qualifications inclusive corresponding risk assessment
Upgrade of window server: preparation of qualification documents (operation of SQL-cluster, requirements-specifications, technical design, risk analysis)
Support upgrade of serialization data base / interface: documentation of user-role-migration
Support of supplier qualification including audit of supplier (DMS- and RA-system implementation)
Adaption of supplier-qualification SOP
Review and adaption of supplier-risk-control-matrix
Review of supplier qualification documents and comparison with risk-control-matrix
Preparation of supplier audit (remote)
Conduction of suppler audit (remote) as lead auditor
Preparation of audit plan and audit report

Jan 2025 - Oct 2025

10 months

Pharma Company

Update of existing quality system, GDP
Concept and realization of quality risk management based on ICH Q9 version 2023
Concept and realization of supplier management on a risk-based approach
Concept and realization of a digital documentation

Dec 2024 - Aug 2025

9 months

Logistic Provider (3PL / 4PL)

Concept for a quality system for a 4PL business
Construction and implementation of a GDP-quality system for the business as 4PL provider
Preparation for an inspection by the competent authority, including registration and WDA application
Support of establish the business, based on GDP requirements

Oct 2024 - May 2025

8 months

Pharmaceutical Companies

Support and realization of migration of the existing SOP document management system after system upgrade
Support and implementation of re-validation of the upgraded SOP document management systems

Jul 2024 - Jan 2025

7 months

Pharmaceutical Company GDP Wholesale

Active support for the responsible person under §52a AMG
Restructure the quality system (global with affiliates)
Set up and implement new quality agreements (global with affiliates)
Update all necessary GDP SOPs and forms for operational GDP activities
Prepare for GDP inspections by the authorities (GAP analysis)
Support understanding and setting up the quality system as a pharmaceutical company (local representative and co-distributor)
Set up a supplier qualification system
Restructure complaints handling and interaction with the German graduated plan officer (Stufenplanbeauftragter §63a AMG)
Process backlog (changes, deviations, CAPA)

Feb 2024 - Dec 2024

11 months

Pharmaceutical Company (Big Pharma)

Qualification of IT and IT infrastructure used in GMP facilities
Administration of technical sites and documentation of qualification records in SAP
Project management with Trello
Support for updating and migrating the electronic data and documentation system
Training users on administration and operational processes
Consultation on conceptual use of the system (digitalization of workflows)
Consultation on data integrity issues
Re-qualification of the system (including risk assessment)

Jan 2024 - Apr 2025

1 year 4 months

Pharmaceutical Company / GDP Wholesale, including APIs

Provision of the role of responsible person under §52a AMG
Provision of the role of responsible person for APIs
Support of the quality system (analysis and updates)

Apr 2023 - Dec 2023

9 months

Head of Quality

Pharmaceutical Company / GDP Wholesale

Act as the responsible person under §52a AMG (listed with authorities)
Act as Head of Quality and lead the quality team
Member of the Senior Leadership Team
Establish a new quality team
Maintain the GDP quality assurance system for the German affiliate
Update all necessary GDP SOPs and forms for operational GDP activities
Prepare for GDP inspections by the authorities (GAP analysis)
Communicate with authorities (ROB)
Lead inspections by ROB to maintain the wholesale operating license (GDP)
Supplier qualification
Customer qualification
Verify contracts with service providers (3PL, suppliers, etc.)
Lead the complaints department
Process backlog (changes, deviations, CAPA)
Lead goods receipt and release of goods to saleable stock
Provide basic GDP training and onboarding
Support supply chain, customer relations, and marketing
Project management and coordination with the parent company

Nov 2022 - Mar 2023

5 months

Pharmaceutical Manufacturer (Pharma)

Generation of SOPs for aseptic manufacturing: feeding primary packaging material, cleaning and sterilization of the manufacturing facility, material and personnel transfer, primary packaging assembly, cleaning and sterilization of the bottling plant, autoclave operation, and room decontamination
Coordination with subject matter experts

Oct 2022 - Mar 2023

6 months

Pharmaceutical Company (Pharma)

Implementation of an electronic document management system (SOP Edition, triboni AG)
Software validation including CSV, based on GAMP5 / 21 CFR Part 11
Ensuring data integrity requirements
Risk assessment for validation
Training for software administration and users
Project management: coordinating and organizing validation with customers, including qualification tests
Creation of software-specific SOPs: system use and access, data integrity, backup and maintenance

Oct 2021 - Feb 2022

5 months

Pharmaceutical Company (Big Pharma)

Implementation of an electronic document management system (SOP Edition, triboni AG)
Software validation based on GAMP5 / 21 CFR Part 11
Ensuring data integrity requirements
Risk assessment for validation
Training for software administration and users
Project management: coordinating and organizing validation with customers, including qualification tests

Sep 2021 - Dec 2022

1 year 4 months

Pharmaceutical Manufacturer (Big Pharma)

Qualification (FAT/IQ/OQ/PQ) of a pull-push machine for injection pen function tests
Configuration of the pull-push machine (user management, reports, parameters, daily checks)
Method transfer (mainly packaging) from development to QC departments
Performing GAP analyses (methods, GMP compliance, data integrity)
Performing risk assessments (methods, GMP compliance, data integrity)
Creating transfer documents (GMP)
Documenting the transfer
Addressing data integrity issues (software)
Project management: coordinating and organizing equipment qualification and transfers, working with QA
Consulting on and implementing data integrity

Jun 2021 - Dec 2021

7 months

Biotechnology Company (GMP)

Qualification of equipment (liquid nitrogen containers, ultra-low freezers, alarm systems)
Risk analysis for equipment and systems
Preparing qualification documents
Project management and supplier communication
Creating periodic review documents (qualification status)
Supporting the quality assurance system (consultant)

Feb 2021 - Feb 2023

2 years 1 month

Biotechnology Company / GDP Wholesale

Developing and setting up the GDP quality assurance system for the German affiliate
Creating all required GDP SOPs and forms for daily GDP operations
Preparing for GDP inspections by authorities
Communicating with authorities (ROB)
Participating in inspections to get the wholesale license (GDP)
Serving as the responsible person under §52a AMG (as acknowledged by the authority)
Implementing the supplier qualification system
Qualifying customers
Reviewing contracts with service providers (3PL, GDP transport, telephone hotline for complaints, etc.)
Tracking goods via SAP
Providing basic GDP training
Project management and coordinating with the parent company

Sep 2020 - Dec 2020

4 months

Pharmaceutical Manufacturer (Big Pharma)

Methods and knowledge transfer (combinatorial medical devices) for incoming goods inspections from development to the quality control departments
Implementation of GAP analyses (methods, GMP compliance, data integrity)
Implementation of risk assessment (methods, GMP compliance, data integrity)
Establishment of transfer documents (GMP)
Implementation and documentation of the transfer
Project management (coordination and organization of transfers, coordination with QA)
Consulting and implementation of data integrity

Oct 2019 - Aug 2020

11 months

Pharmaceutical Manufacturer (Big Pharma)

Methods transfers (different locations) of functional tests and dimensional determinations for primary packaging materials
Methods validation of functional tests and dimensional determinations for primary packaging materials in the QC
Processing and evaluation of statistical procedures for methods validation
Creation of methods (SOPs) (e.g. tension-pressure, optical measurements)
Implementation of specific test programs taking into account data integrity requirements on Zwick testing machine
Creation of instructions and evaluations on optical test measuring instruments, taking into account data integrity requirements
Project management (temporal and organizational planning of transfer and method development activities)
Agreements with device and software manufacturers (Zwick)
Consideration of 21 CFR Part 11 / Data Integrity
Coordination with QA
Material qualification of combinatorial medical devices – autoinjectors and primary packaging materials
Software products used for material qualification: SAP and TrackWise
Development of processes for material qualification
Assumption of incoming goods inspections for primary packaging materials and medical devices
Test methods implementation, including software adaptations taking into account applicable data integrity requirements
Test methods validation according to ICH Q2
Test methods transfer (internal from development to QC laboratory)

Jan 2019 - Present

7 years 4 months

Manufacturers of Pharmaceuticals

Qualification IT infrastructure, incl. documentation
Creation of operating documents of the IT structure components and IT qualification documents
Qualification / validation GxP relevant back-up system (CSV), incl. documentation
Support of GAP and IT risk analysis
Conceptual GxP consulting on IT processes taking into account the current data integrity requirements
Creation of a holistic container closure integrity test (CCIT) concept for a new product to be introduced
Dossier for the preparation of an FDI inspection with regard to CCIT presentation
Gap analysis and actual state considering required conditions from USP 1207
Consultation and integration of all CCIT stakeholders affected in the product cycle
Project management
Advice on the selection of new CCIT methods, including creation of CCIT requirements profile with data integrity requirements and supplier visits

Jul 2018 - Sep 2019

1 year 3 months

Pharmaceutical Manufacturer (Big Pharma)

Process transfer (combinatorial medical device – autoinjectors) and knowledge transfer (incoming goods inspection) from development to production or goods receipt
Establishment of the transfer process: development in production
Establishment of transfer documents (GMP), including GAP analyses (processes and IT requirements)
Implementation and documentation of the transfer
Project management
Consulting and implementation of data integrity

Jan 2018 - Oct 2018

10 months

Pharmaceutical Company (GMP/GDP Project)

Support of the responsible person GDP
Process and quality management
Implementation and support of serialization project (CMO onboarding, validation support OQ/PQ, creation of relevant SOPs, data integrity)
Support establishment of a quality assurance system according to GMP / GDP
Consulting document and data management solution according to GMP
Participation in ongoing deviation change and CAPA processes
Training of employees: QM system and DMS

Jun 2017 - Sep 2017

4 months

Pharmaceutical Company (GMP/GDP Project)

Consulting and project work: process and quality management
Support establishment of a quality assurance system according to GMP / GDP
Consulting document and data management solution according to GMP
Creation of questionnaires for IT solutions (data integrity), regulatory affairs, pharmacovigilance
Training of employees: QM system and DMS

Mar 2017 - Dec 2017

10 months

Biotechnology Company (GMP Project)

Consulting and project work: process and quality management
Support establishment of a quality assurance system according to GMP
Consulting document and data management solution according to GMP
Training of employees: QM system and DMS

Jan 2017 - Present

9 years 4 months

Quality Officer

Pharmaceutical Company – GDP Wholesale Company

Quality officer for the operational maintenance of the virtual quality assurance system
Operational implementation of all quality assurance measures according to GDP (e.g. annual quality reports, self-inspections, risk management, changes management, training)
Inspection readiness
Participation at inspections through authorities
Responsible for data backup and recovery
Responsible for data integrity
Responsible for maintaining CSV
Project management

Jun 2016 - Dec 2016

7 months

Pharmaceutical Company - Wholesale Company

Establishment of a virtual quality assurance system for pharmaceutical wholesalers
Implementation of electronic SOP management system and quality assurance system
CSV, computer system validation
Establishment of a quality assurance system for obtaining the wholesale operating license according to AM-HandelsV (GDP)
Creation of all relevant SOPs and quality documents
Preparation and CAP analysis for the implementation of the GDP guideline
Member for the implementation of the GDP guideline at international level
Project management
Development, establishment and implementation of extended quality management: change control, variances, CAPA processes, risk management

Jan 2016 - Mar 2018

2 years 3 months

Pharmaceutical Manufacturer (Big Pharma)

Interim laboratory coordinator (including staff coordination) at quality control
Responsible for the development and method validation of CCIT methods (vacuum decay, blue dye)
Method validations of adhesive sliding friction methods (tensile-compression machines)
Implementation and qualification of devices in quality control
Validation (CSV) of the device software and network connection, including GAP analyses
Support and supplementation of quality assurance components (GMP process, documentation, risk management)
Supervision and responsibility of method transfers (international)
Handling of customer projects
Support and responsibility of PPQs (product performance qualification) for packaging materials
Supervision and support of QA processes such as deviations, changes and CAPA measures
Preparatory measures for audits by FDA and customers
Consulting and implementation of data integrity solutions
International project management

Oct 2015 - Present

10 years 7 months

Pharma Company QaaS

Supervision / support of electronic SOP management as a service
Change management and documentation of the software
Risk management for IT processes
Training of the application
Validation of the software (CSV) and continuous maintenance of the validated state
Data integrity responsibility and implementation

May 2015 - Present

11 years

Managing Director and Owner

trimedes LifeScience UG (Hb)

Oct 2013 - Oct 2016

3 years 1 month

Head of QA

Biotechnology Company (GMP Project)

Consulting and project work: process and quality management
Establishment of quality assurance system according to GMP (incl. self-inspections)
Construction of aseptic production unit
Establishment of process chain biological drugs according to GMP
Implementation of document and data management solution according to GMP
Validation (CSV) of the software
Responsible for data backup and recovery
Responsible for data integrity
Preparation and participation in inspection to obtain a GMP manufacturing permit according to PIC/S
Training of employees: QM system and DMS system according to GMP
Qualification of devices and plants according to GMP
Qualification of an incubator production plant
Process validations
Validation of plant and device software, including connected infrastructure
Qualification of contract manufacturers, suppliers (incl. IT) and testing laboratories, according to GMP (including audits)
Project management

May 2012 - May 2012

1 month

Workshop Laser Manufacturer: Medical Device

Preparation, implementation and report on requirements for device manufacturers for medical devices ISO 13485

Jan 2012 - Sep 2015

3 years 9 months

Pharmaceutical Companies

Support of the responsible person GDP
Implementation of electronic SOP management system
Computer system validation (SOP management system)
Project participation for the serialization of pharmaceuticals (securPharm)
Preparation and CAP analysis for the implementation of the GDP guideline
Project support and management for the conversion to temperature-controlled drug transports
Contact person for logistics service providers (storage and transport of medicines)
Carrying out self-inspections in the areas: pharmaceutical quality complaints, global logistics
Development, establishment and implementation of extended quality management: change control, variances, CAPA processes, risk management
Revising and rebuilding SOPs
Performance of the role QVC, quality validation compliance of the internal SAP solution COMET
Preparation and planning for the introduction of the CCM system (cold chain management)
Participation in due diligence audits on behalf of the responsible person GDP in several 3PLs

Nov 2011 - Mar 2012

5 months

Biochar and Feed Manufacturers

Analysis of the necessary requirements for the production of feed from biochar
Presentation of the necessary quality assurance systems
Introduction to ISO 9001:2008
Preparation of internal audits
Internal audit of the production site (according to ISO 9001:2008 and GMP+)

Sep 2011 - Dec 2011

4 months

Quality Officer GDP

Pharmaceutical Company GDP

Redesigning the quality management manual
Revision and creation of SOPs
Prepare training courses
Preparing an official inspection for wholesale approval
Conceptual support for pharmaceutical quality assurance (complaints/recalls)
Preparation of internal audits

Apr 2011 - Oct 2011

7 months

Medical Device Manufacturers

Advice on quality management
Creation of the quality management manual
Creation of process descriptions
Creation of work instructions
Creating forms

Oct 2010 - Dec 2011

1 year 3 months

Head of Quality Assurance and Quality Control GDP

Pharmaceutical Company / Generic GDP

Restructuring of the existing QM system
Creation of the quality management manual
Creating SOPs
Conduct training
Preparation for inspection to obtain a wholesale license according to §52a AMG
Participation at inspection by the government of Tübingen (wholesale license granted)
Preparation and execution of audits at the assembler and supplier
Project management

Mar 2010 - Mar 2010

1 month

Munich, Germany

Funding Advice Leading-Edge Cluster BMBF – Munich

Funding advice for the application within the BMBF Leading-Edge Cluster M4 (Munich) Competition for Biotech, Pharma and CRO's
Preparation of project description
Creation of network plan
Creation of network description
Examination of economic and scientific data
Preparation of AZK forms

Aug 2009 - May 2012

2 years 10 months

Head of Quality Assurance

Biotechnology Company (GMP Project)

Consulting and project work: process and quality management
Construction of an aseptic production unit
Establishment of quality assurance according to GMP
Establishment of the process chain for biological drugs according to GMP
Implementation of a document and data management solution according to GMP, including data integrity
Preparation for and participation in inspections to obtain a GMP manufacturing license under AMG
Training employees: QM system and DMS system according to GMP
Validation of the DMS system according to GMP
Administration of the DMS system
Qualification of equipment and facilities according to GMP
Process validation according to GMP
Computer system validation (CSV)
Preparation of approval dossiers
Auditing contract manufacturers, suppliers (including IT), and testing laboratories according to GMP
Conducting self-inspections
Project management

Oct 2008 - Jun 2009

9 months

Heidelberg, Germany

Funding Advice Leading-Edge Cluster BMBF - Heidelberg

Funding advice for applications in the BMBF Leading-Edge Cluster BioRN competition for biotech, pharma, and CROs
Compilation and management of a project group
Kick-off meeting
Creation of a project description
Creation of a network plan
Creation of a network description
Review of economic and scientific data
Preparation of AZK forms

Apr 2008 - Apr 2008

1 month

Large Research Institute

Concept development for the FLUGS information service and internal knowledge management
Analysis of the current state of the FLUGS information service
Analysis of the current state of knowledge management processes
Analysis of the IT processes involved; evaluation and concept development for the project

Jun 2007 - Apr 2008

11 months

Biotechnology Company

Implementation of an SOP management system, mapping of GxP processes (GLP/GMP)
SOP review planner
SOP training planner
21 CFR Part 11 compliance
Computer system qualification and validation
Data integrity and traceability
Creation of IT SOPs
Auditing of GLP/GMP processes

Feb 2007 - Jun 2009

2 years 5 months

Clinical Research Organisation (CRO)

Support and implementation of quality management according to GCP
SOP administration (writing and managing)
GxP auditing of software vendors and suppliers
Supervision of self-inspections

Jan 2007 - Sep 2008

1 year 9 months

Managing Director and Shareholder/Owner

Intakt LifeSciences GmbH

Jul 2006 - Dec 2006

6 months

trimedes LifeSciences

Concept development for a product lifecycle management solution based on the basics of GXP and the requirements of the FDA (21 CFR Part 11)
Modules for GLP, GMP, GCP, and eCTD

Jun 2006 - Dec 2017

11 years 7 months

Managing Director and Owner

trimedes LifeScience

Jan 2005 - Jun 2006

1 year 6 months

Biotechnology Company

Preparation of specification and qualification documentation (encapsulation machine)
Specifications, risk assessment, qualification report
Illustration of GLP and GMP processes for process control and documentation software
Analysis of existing quality systems and processes
Development of a concept for mapping GLP and GMP processes
Creation of a decision matrix (system)
Risk assessment of processes and implementation
Mapping of all processes according to GLP and GMP
Documentation of processes and work steps

Aug 2003 - Mar 2005

1 year 8 months

University Project with Pharma Participation

Creation of URS and functional specifications for documentation software
Development and implementation of project management
Approval of specifications
Creation of manuals

Apr 2003 - Jun 2006

3 years 3 months

Managing Director and Shareholder/Owner

trimedes GmbH

Jul 2002 - Mar 2003

9 months

Munich, Germany

Project Lead for Documentation Software

mediNET GmbH

Jun 2001 - Jun 2002

1 year 1 month

Head of Data Warehouse

Service Provider for Oncological Data and Knowledge Management

Designing and architecting an oncology data warehouse
Acquiring, cleaning, checking plausibility, structuring, and processing clinical data (GCP)
Assessing risks and validating data sets and processes
Analyzing data using SAS warehouse tools

Apr 2001 - Jun 2002

1 year 3 months

Planegg, Germany

Head of Data Warehouse for Clinical Trials and Oncology

Oncology World GmbH

Apr 1995 - Mar 2001

6 years

Munich, Germany

Research Assistant with Project Management

Bavarian Nordic

Jan 1995 - Mar 2001

6 years 3 months

Study Director for Preclinical Studies

Biotechnology Company

Construction and commissioning of laboratories (cell culture according to S2, laboratories according to S2 and S1, isotope laboratory)
Acceptance of autoclaves, water system, workbenches
Introduction of GLP standard
Review and selection of suppliers
Creation of SOPs (administration, equipment, procedures, storage of raw material, storage of certificates for clinical trials, experiments, etc.)

Jun 1993 - Mar 1995

1 year 10 months

Biberach, Germany

Employee

Thomae Biberach

Jul 1987 - May 1993

5 years 11 months

Oberschleißheim, Germany

Employee

GSF Neuherberg

Industry Experience

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

Experienced in Biotechnology, Pharmaceutical, Information Technology, Professional Services, Healthcare, and Education.

Biotechnology

Pharmaceutical

Information Technology

Professional Services

Healthcare

Education

Business Area Experience

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

Experienced in Quality Assurance, Project Management, Operations, Strategy, Research and Development, and Information Technology.

Quality Assurance

Project Management

Operations

Strategy

Research and Development

Information Technology

Languages

German

Native

English

Advanced

Certifications & licenses

Service Provider Qualification in the GDP Environment

Forum

GDP Update 2024

ECA (Concept Heidelberg)

GDP for Active Pharmaceutical Ingredients (APIs)

Concept Heidelberg

GDP Update 2023

ECA (Concept Heidelberg)

Pharma Supply Chain: GDP Requirements and Certification for Logistics Vendors

Concept Heidelberg

GDP Update 2022

ECA (Concept Heidelberg)

GDP Update 2021

ECA (Concept Heidelberg)

Counterfeiting Directive and Serialization – Problems, Challenges and Solutions – a practical seminar

MEGRA

GDP Audit

MEGRA

Risk Management: EU GMP Guide Part III

Data Integrity Concept

ECA/Concept Heidelberg

GMP and GDP inspections, legal requirements, preparation and practical information

MEGRA

ICH Q9 (Quality Risk Management) Training Course

ECA

Cloud Computing in the GxP Environment

Concept Heidelberg

Understanding and Implementing the New EU-PIC/S Annex 11

Labcompliance Dr. Ludwig Huber

Validation Using Electronic and Digital Signatures in Regulated Environments

Labcompliance Dr. Ludwig Huber

Validation and Part 11 Compliance of Electronic Document Management Systems

Labcompliance Dr. Ludwig Huber

Validation and Use of Cloud Computing in FDA Regulated Environments

Labcompliance Dr. Ludwig Huber

GDP in the pharmaceutical industry

MEGRA

Ready, GMP basic training on SAP in the field of quality management

customer-internal training

GMP: Ready, GMP training

Maas & Peither AG

Responsible persons of a pharmaceutical company – tasks, responsibility and liability

MEGRA

Quality Assurance in Pharmaceutical Companies: Implementation and Updating

MEGRA

Good Manufacturing Practice – Training

Prof. Dr. Christa Schröder, Albstadt Sigmaringen University of Applied Sciences

Good Clinical Practice – Training

CMC Pharma GmbH

Good Laboratory Practice: Basics – Regulations – Implementation

Data Warehouse Architecture Course

SAS Institute GmbH

SAS/Warehouse Administrator Software Course

SAS Institute GmbH

General Basics for SAS Programmers and Data Warehouse Developer

SAS Institute GmbH

Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management Course

British Association of Research Quality Assurance

Introduction To Good Laboratory Practice Course

Country Consultancy

Further training for project managers and biological safety officers

Max Planck Institute of Biochemistry Martinsried

Statistics

Experience

Total positions 53

Experience in Biotechnology 33.5 y

Avg length 2 y 2 m

Longest experience 11 y 6 m

Global Experience

Countries worked in 1 (Germany)

Primary country Germany

Expertise

Recent roles Head of Quality, Quality Officer, Managing Director and Owner

Main industries Biotechnology, Pharmaceutical, Information Technology

Main business areas Quality Assurance, Project Management, Operations

Qualifications

Certifications earned 32

Profile

Created

March 2026

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Frequently asked questions

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

Where is Frank based?

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

What languages does Frank speak?

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

How many years of experience does Frank have?

Frank has at least 39 years of experience. During this time, Frank has worked in at least 14 different roles and for 42 different companies. The average length of individual experience is 1 year and 9 months. Note that Frank may not have shared all experience and actually has more experience.

What roles would Frank be best suited for?

Based on recent experience, Frank would be well-suited for roles such as: Head of Quality, Quality Officer, Managing Director and Owner.

What companies has Frank worked for in recent years?

In recent years, Frank has worked for Pharmaceutical Company (Big Pharma - Manufacturer), Midsize Pharma Company (Manufacturer), Pharma Company, Logistic Provider (3PL / 4PL), and Pharmaceutical Companies.

Which industries is Frank most experienced in?

Frank is most experienced in industries like Biotechnology, Pharmaceutical, and Information Technology. Frank also has some experience in Professional Services, Healthcare, and Education.

Which business areas is Frank most experienced in?

Frank is most experienced in business areas like Quality Assurance, Project Management, and Operations. Frank also has some experience in Strategy, Research and Development, and Information Technology.

Which industries has Frank worked in recently?

Frank has recently worked in industries like Biotechnology, Pharmaceutical, and Transportation.

Which business areas has Frank worked in recently?

Frank has recently worked in business areas like Operations, Strategy, and Quality Assurance.

Does Frank have any certificates?

Frank has 32 certificates. Among them, these include: Service Provider Qualification in the GDP Environment, GDP Update 2024, and GDP for Active Pharmaceutical Ingredients (APIs).

What is the availability of Frank?

Frank will be available part-time from April 2026.

What is the rate of Frank?

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