Nicole Melzer-Interim Quality Manager, GMP and FDA Audit Preparation
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Experience
Interim Quality Manager, GMP and FDA Audit Preparation
Compliance Service Nord
With over 30 years of experience implementing and maintaining cGMP regulations, I support our clients in improving and streamlining their quality management (QM) processes. My passion for details, strategic and analytical mindset, and my creative, responsible team-player attitude set me apart. I prepare thorough GAP analyses and establish best-practice processes that meet guidelines - while remaining lean, efficient and practical.
Head of Pharma Services
Lichtenheldt GmbH
- Customer project management
- Stability studies
- Product and analytical method transfer and validations
- Development of semi-solid formulations
- Deviation and CAPA management
GMP Compliance Manager (GMP/cGMP)
Lichtenheldt GmbH
- Implemented FDA regulations across the company and successfully passed the FDA pre-approval inspection
Freelancer in Pharmaceutical Sterile Production
- Setting up regulatory documents, specifications and peptide hormone test strategies according to FDA/GMP guidelines for small-scale aseptic filling
- Testing excipients, APIs and bulk products
- Establishing new primary packaging materials
- Validating LIMS LabWare modules
Interim Quality Management Representative, Dental Products
- Conducting external and internal audits
- Creating SOPs and technical documentation in STED format
- Improving risk management
- Assessing biocompatibility studies
- Validating ETO sterilization
- Quality improvement at a Japanese supplier
- Preparing for ISO 13485:2016, MDSAP and FDA audits
- Implementing MDR requirements
- Registrations in the USA, Canada and Japan
- Contact person for the notified body
- Training employees
Freelancer, Pharmaceutical Industry
- Evaluation of extractables and leachables studies for biotech plastic production aids
Freelancer, Pharmaceutical Industry (Sterile Production)
- Supplier audits and quality improvements at peptide hormone primary packaging suppliers (syringes, vials and stoppers)
- Creating approval documents, specifications and lyophilization test strategies for reduced testing of primary packaging in aseptic filling
Freelancer, Pharmaceutical Industry (Sterile Production)
- Improvement project to minimize particle contamination in injectable products during aseptic filling and with incoming packaging materials
- Lyophilization
Interim Lab Head, Biopharmaceuticals
- Managing the lab
- Overseeing quality control, stability testing, and release testing
- CAPA and changes
- Supporting QC manager with qualifications and validations
- Creating SOPs and training
- FDA compliance
Quality Management Representative and Head of QA/QC
Transcoject GmbH
- Pharmaceutical primary packaging (pre-filled syringes) and aseptic filling
- ISO 13485 and FDA 21 CFR Part 820
Head of Pharmaceutical Primary Packaging and Medical Device Production
Transcoject GmbH
- QA, QC, production, planning, validation, development, and aseptic filling
Head of Pharmaceutical Primary Packaging
Transcoject GmbH
- QA, QC, production, planning, validation, and development
Quality Management Representative and Head of Quality Assurance/Control and Validations
Transcoject GmbH
Pharmaceutical Quality Assurance and Lab Manager
Transcoject GmbH
- Analytics and microbiology
- Gamma and EO sterilization validations
Quality Assurance and Validation, Analytical Lab
Glaxo Wellcome GmbH & Co.
- Deputy lab manager
- Lean Six Sigma advocate
Transfer Coordinator Analytical Laboratory
Glaxo Wellcome GmbH & Co.
- Validation Coordinator
- Deputy Lab Manager
- Lean Six Sigma Advocate
Transfer Coordinator and Validations Analytical Laboratory
Glaxo Wellcome GmbH & Co.
- Lean Six Sigma Advocate
Chemical Lab Technician in the Analytical Laboratory
Glaxo Wellcome GmbH & Co.
- Qualification of analytical instruments and validation of analytical methods
Industry experience
See where this freelancer has spent most of their professional time.
Experienced in Pharmaceutical, Healthcare, Manufacturing, and Biotechnology.
Business area experience
See which departments and functions this freelancer has contributed to most.
Experienced in Quality Assurance, Product Development, Production, Project Management, Operations, and Research and Development.
Summary
30 years of experience in implementing and maintaining GMP regulations and carrying out validations in the pharmaceutical and medical device industry
- Over 19 years of experience leading, validating and managing projects in QA/QC/laboratory in the pharmaceutical industry; good knowledge of aseptic manufacturing and prefillable syringes
- Over 13 years of experience leading, validating and managing projects in QM/QA/certification/production/sterilization (ETO/Gamma) in the medical device industry (including sterile primary packaging)
Skills
- Lims Labware
- Xeri
- Trackwise
- Sap
- Real
- Register
- Microsoft Office
- Qs-Stat
- Minitab
- Gus
- D.3
Languages
Education
Technical School
State-certified chemical technician · Chemical Technology · Germany
Drägerwerk AG
Chemical Laboratory Technician · Lübeck, Germany
Certifications & licenses
Lean Six Sigma Advocate
Statistics
Experience
Global experience
Expertise
Qualifications
Profile
Frequently asked questions
Have questions? Find more information here.
Nicole is based in Rohlstorf, Germany and can operate in on-site, hybrid, and remote work models.
Nicole speaks the following languages: German (Native), English (Advanced).
Nicole has at least 35 years of experience. During this time, Nicole has worked in at least 17 different roles and for 4 different companies. The average length of individual experience is 2 years. Note that Nicole may not have shared all experience and actually has more experience.
Based on recent experience, Nicole would be well-suited for roles such as: Interim Quality Manager, GMP and FDA Audit Preparation, Head of Pharma Services, GMP Compliance Manager (GMP/cGMP).
Nicole's most recent position is Interim Quality Manager, GMP and FDA Audit Preparation at Compliance Service Nord.
In recent years, Nicole has worked for Compliance Service Nord and Lichtenheldt GmbH.
Nicole is most experienced in industries like Pharmaceutical, Healthcare, and Manufacturing. Nicole also has some experience in Biotechnology.
Nicole is most experienced in business areas like Quality Assurance, Production, and Product Development. Nicole also has some experience in Project Management, Operations, and Research and Development.
Nicole has recently worked in industries like Pharmaceutical.
Nicole has recently worked in business areas like Quality Assurance, Product Development, and Project Management.
Nicole holds a Doctorate in Chemical Laboratory Technician from Drägerwerk AG.
Nicole has 1 certificate: Lean Six Sigma Advocate.
The availability of Nicole needs to be confirmed.
Daily rate distribution
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Average rates for similar positions
Rates are based on recent contracts and do not include FRATCH margin.
The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.
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.
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