Biopharmaceutical Consultant | Interim Quality Director | GxP Certified Auditor

3/2022 – 12/2022

- Leading inspections by the german Health Authorities, regulatory agencies, and customers.
- Representing Quality function to achieve site goals and maintain compliance to corporate quality standards and the regulatory agencies around the world.
- Active member of the site leadership team, operational leadership team, and support the management team where required.
- Establishing the strategic plans and goals for the site Quality organization by making final quality decisions on administrative and operational matters at the site.
- Leading a team of 90 professionals within the Quality Unit including Quality Systems, Quality Operations, Regulatory Affairs and Quality Control.
- Leading the quality strategy for introducing new products into the site through all on-going product transfer projects.
- Ensuring Quality Agreements and Third Party Management with manufacturing and distribution subcontractors are in place, in use and updated.

Qualitätsmanagement / QS / QA (IT)

2/2019 – 10/2019

- Responsible for coordinating all efforts involved in the transfer of new chemistry products, instrument products, and manufacturing equipment from R&D into reagent and instrument manufacturing.
- Direct responsibility for delivering key focus products on time, within budget and on time.
- Monitoring project scope, schedule and costs to ensure all remain on track with the contract and with financial performance targets.
- Proactively lead quality control and risk assurance activities to ensure project deliverables are met according to regulatory and client requirements.
- Coordinating the activities between Chemistry and Engineering research and development, Program Management, Supply Chain, Purchasing, Materials Management, Quality Assurance, Software, Service, Manufacturing and Regulatory departments.

Enterprise project management (EPM)

3/2018 – 9/2023

Performing GMP/ GLP/ GDP audits on behalf pharmaceutical and biotech customers as of Pfizer, Baxter, Amgen, BioVectra, Elanco, Medtronic etc.
- Responsible for audit preparation and audit activities for global regulatory filings (US FDA, EMA, MHRA).
- Acting as the primary audit contact for SQA, audit notification and consolidation point for receiving, processing, and reporting all audits findings.
- Providing technical audit expertise to prepare the whole audit process in communication with the supplier auditees.

Auditor, Gute Herstellungspraxis (GMP), Gute Laborpraxis (GLP), Qualitätslenkung

4/2017 – 8/2018

- Building & driving a new Quality vision and strategic objectives within the whole organisation.
- Acting as the key contact person for Health authorities, developing constructive relationship, and supporting filing of product/process changes.
- Establishing network wide QA/QC priorities and key objectives to reduce turnaround time, the cost of poor quality and improve the compliance to regulations.
- Review/approval of CMO batch records and associated GMP documentation (i.e. laboratory/manufacturing investigations, deviations, complaint investigations and validation documentation).
- Generation and maintenance of Quality Agreements.
- Support regulatory inspections and lead inspection preparation teams as needed.
- Establishing & Improving Supplier Qualification Programs.
- Conducting as GMP lead auditor internal, client, and supplier audits.

Gute Herstellungspraxis (GMP), Projektdurchführung

10/2016 – 3/2017

- Set-up Quality Assurance and Control strategy after the Sigma Aldrich Research Chemical Acquisition.
- Established and monitored a new Change Control Notification strategy reducing customer complaints by a 40%.

Projekt-Qualitätssicherung

2/2016 – 8/2016

- Served as Good Distribution Practices expert providing 15+ in-house trainings to the company employees.
- Facilitated the quality performance oversight of the external GMP warehouses.

Gute Herstellungspraxis (GMP)

9/2013 – 12/2015

- Responsible for Continuous Improvement in Quality Management Systems as of Deviations, CAPA, Change Control & Risk Management.
- Coordination of regulatory GMP inspections as of FDA, ANVISA and several European health authorities.
- Monitoring effectiveness of quality systems, including performance of self-inspections, metrics monitoring and participation in management reviews.
- Responsible for the establishment and reporting of Quality KPIs (Key Performance Indicators).

Gute Herstellungspraxis (GMP)

1/2012 – 9/2013

- Led the 15+ employees Batch Disposition team at Sandoz Unterach for parenteral products.
- Ensured GMP compliance of the sterile pharmaceutical products through the product life cycle from development, approval, and launch.
- Guaranteed pre-approval and routine regulatory inspection readiness to prepare for audits by global Regulatory Health Authorities.

Gute Herstellungspraxis (GMP)