Curriculum Vitae
I am a highly motivated professional with a 7-year proven track record in the pharmaceutical and biotech industry. I help corporations implement robust quality management, data integrity, and privacy systems aligned with FDA/EMA/ICH/OECD GxP guidelines, as well as CIPP/US/EU standards. With profound expertise in project management and Six Sigma methodologies, I am dedicated to continious improvement and process enhancement to drive efficiency and excellence.
WORK EXPERIENCE
01/11/2022 – 31/12/2023 Remote, Germany
FREELANCE CONSULTANT DATA INTEGRITY SANOFI-AVENTIS DEUTSCHLAND GMBH
Implemented the Data Integrity Program in strict adherence to Eudralex Vol. 4, FDA 21 CFR Part 11, WHO
Annex 5, Sanofi guidelines, and GDocP standards
Successfully completed process and system DI-Assessments for core API departments, including the
creation of process data flow mappings, system gap assessments, and associated risk assessments
Led the planning and implementation of remediation activities
Created audit trail and access management concepts
Established and modified documentation in instruction, manufacturing and analytical documents to meet stringent data integrity requirements
01/06/2022 – 31/10/2022 Remote, Germany
FREELANCE PROJECT MANAGER VOLKSWAGEN AG CARIAD
Drove innovation and be a part of building a leading tech stack for a safer, sustainable and unified architecture
Provided strategic support to shape the overall portfolio and roadmap for customer functions, enablers, as well as hardware and digital services
01/12/2020 – 31/05/2022 Tübingen, Germany
COORDINATOR GMP PRODUCTION & DATA INTEGRITY CUREVAC REAL ESTATE GMBH
Established a robust link between quality and production management: serving as the liaison for clinical production on the batch release board,
monitoring the production document flow and overseeing the issuance and inspection of batch records, and meticulously preparing the batch records for quality management scrutiny
Led the production department in collecting Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) crucial for ensuring data integrity
Held the role of change owner for production-related changes demonstrating leadership and attention to detail
Spearheaded the creation and execution of Corrective and Preventive Actions (CAPAs), deviations, along with risk and root cause analyses
Drove the adaption and enhancement of document management processes
Developed and reviewed Standard Operating Procedures (SOPs), ensuring compliance and operational efficiency
15/07/2019 – 30/11/2020 St.Leon-Rot, Germany
REPRESENTATIVE COMPLIANCE & PRIVACY CANOPY GROWTH GERMANY GMBH
Ensured a compliant Data Governance framework at the production site
Regularly provided quarterly reports to the Manager of Compliance and Data Privacy Europe
Conducted and assisted employees in identifying pertinent processes/projects for the initial privacy assessment
Consulted and supported colleagues in smart documentation approaches for process documentation
Successfully finalized compliance and privacy-related documents
Played a key role in raising awareness among employees about compliance and data protection topics
Served as the representative and contact person for the compliance code of conduct and privacy matters
Dedicated to optimize on-site compliance and privacy procedures
15/01/2024 – Ongoing Remote, Germany
FREELANCE CONSULTANT PROJECT MANAGER SANOFI-AVENTIS DEUTSCHLAND GMBH
Project Manager for redesign of Building Access Management in accordance to GxP and security regulations planning and managing a seven-figure-budget
Supplier coordination during modification of accesses and access control systems, including qualification and validation procedures
Creation and evaluation of GAP analysis related to physical access, access control systems, and authorization processes
Revision and adaption of SOPs and process descriptions
15/07/2019 – 30/11/2020 St. Leon-Rot, Germany
SPECIALIST PRODUCTION PROCESSES CANOPY GROWTH GERMANY GMBH
Established a robust link between quality and production management: monitoring the production document flow, overseeing the issuance and inspection of batch records, and meticulously preparing the batch records for quality management scrutiny
Represented successfully the document and production processes in audits
Developed, optimized and reviewed Standard Operating Procedures (SOPs), and associated protocols for meticulous process documentation ensuring compliance and operational efficiency
Led the development, validation and implementation of production processes
Conducted Corrective and Preventive Actions (CAPAs), deviations, along with risk and root cause analyses
Change owner for production-related changes demonstrating leadership and technical expertise
Documented medical cannabis commerce under the qualified person (QP) in strict adherence to §18 BtMG ensuring compliance
Monitored the incoming goods of medical cannabis, primary packaging, and labels
Organized and implemented comprehensive trainings and practical process instructions in strict adherence to QMS standards ISO 9001
Managed the creation, optimization and maintenance of training materials
Administered the internal training database and training system
Conducted evaluations of production room monitoring utilizing Testo monitoring systems
01/01/2018 – 15/07/2019 Stuttgart, Germany
ONLINE SHOP OWNER FREELANCE
Established and managed of an data privacy compliant e-commerce online shop, emphasizing secure payment gateways and transparent privacy policies
Successfully implemented sales strategies, leveraging a deep understanding of target audiences and optimizing user experiences to drive revenue growth
Authored compelling travel blogs, capturing first-hand experiences and introducing diverse marketing and remuneration models for monetization
15/05/2017 – 16/09/2017 Frankfurt am Main , Germany
OTC CONSULTANT BROCKS'SCHE PHARMACY
Provided consulting and facilitated over-the-counter (OTC) sales for pharmaceuticals, dietary supplements and cosmetics
Executed and meticulously documented daily analytical tests of pharmaceuticals, ensuring rigorous quality control
Managed the handling of incoming pharmaceuticals withing the cold chain, emphasizing proper storage and distribution protocols
Maintained and monitored inventory, ensuring efficient stock levels and contributing to seamless supply chain management
01/01/2017 – 31/03/2017 Frankfurt am Main, Germany
INTERN OTC CONSULTING & PRODUCTION METROPOLITAN PHARMACY
Conducted the production of pharmaceuticals on small scale and batches, including formulation, compounding, and rigorous testing to ensure product efficacy and safety
Conducted pharmaceutical raw material analysis, adhering to quality management system standards and maintaining comprehensive documentation
Provided expert consulting and facilitated over-the-counter (OTC) sales for a range of products, including pharmaceuticals, dietary supplements, and cosmetics utilizing ERP systems
Maintained and monitored inventory, ensuring efficient stock levels and contributing to seamless supply chain management
01/10/2016 – 31/12/2016 Berlin, Germany
INTERN PARENTERAL PRODUCTION & ANALYTICS CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN
Provided support for GMP production of cytostatics and parenteralia in cleanrooms C and B, utilizing LAF systems
Managed the manufacturing pharmaceuticals on small scale and batches, ensuring adherence to quality management system standards
Executed pharmaceutical analytics of raw substances and pharmaceuticals within the quality control department
Conducted sterilization of infusion solutions and played a key role in the preparation of clinical trial pharmaceuticals
Compiled pharmaceutical raw substances and materials for production, demonstrating attention to detail
Handled pharmaceutical logistics for finished medicinal pharmaceuticals and infusion solutions utilizing a semi-automatic fulfillment system
13/08/2015 – 10/09/2015 Berlin, Germany
INTERN PRODUCTION SAINT CHARLES PHARMACY
Conducted the production of pharmaceuticals on small scale and batches, including formulation, compounding, and rigorous testing to ensure product efficacy and safety
Conducted pharmaceutical raw material analysis, adhering to quality management system standards and maintaining comprehensive documentation
Provided expert consulting and facilitated over-the-counter (OTC) sales for a range of products, including pharmaceuticals, dietary supplements, and cosmetics utilizing ERP systems
Maintained and monitored inventory, ensuring efficient stock levels and contributing to seamless supply chain management
27/09/2013 – 29/11/2013 Düsseldorf & Berlin, Germany
INTERN ONLINE EDITORIAL VERLAGSGRUPPE HANDELSBLATT GMBH
Engaged in writing and publishing articles and news reports, showcasing research, literary and journalistic qualities
Collaborated with Holzbrink publishing group subsidiaries to facilitate the publication of articles
15/07/2013 – 23/08/2013 Munich, Germany
INTERN PORTFOLIO MANAGEMENT SHARES MUNICH ERGO ASSET MANAGEMENT
Conducted comparative analyses of products and providers in both qualitative and quantitative sustainability research
Executed balance sheet comparisons for SCD-Depot-Bank, demonstrating proficiency in financial analysis
Researched and assessed the financial impact of the „Media for Revenue“ and „Media for Equity“ strategy for the ProSiebenSat1 Group
01/06/2012 – 15/08/2012 New York City, United States
INTERN PROGRAM & MARKETING NFTE NETWORK FOR TEACHING ENTREPRENEURSHIP
Completed a NFTE training, acquiring valuable skills in entrepreneurship
Actively participated in development and fundraising projects, contributing to successful initiatives
Engaged in program, marketing, and communication projects for non-profit companies, showcasing a commitment to social impact
EDUCATION AND TRAINING
05/07/2022 – 09/07/2022 Dublin, Ireland
CIPP/ US & E CERTIFICATION OF COMPLETION LinkedIn Ireland Unlimited Company Wilton Place, Dublin 2
01/06/2022 – 06/07/2022 Buffalo, WY, United States
SIX SIGMA BLACK BELT Council for Six Sigma Certification C.S.S.C
Address Harmony Living, LLC, 412 N. Main St, Suite 100, 82834, Buffalo, WY, United States
Website https://www.sixsigmacouncil.org/
03/09/2021 – 18/09/2021 Stuttgart, Germany
ADVANCED EXCEL Integrata Cegos GmbH
Address Zettachring 4, 70567, Stuttgart, Germany Website https://www.integrata-cegos.de/
10/09/2020 – 10/09/2020 Heidelberg, Germany
NARCOTICS LAW CERTIFICATION BTMG AH Akademie für Fortbildung Heidelberg GmbH
Address Maaßstraße 28 · D-69123 Heidelberg, 69123, Heidelberg, Germany
Website https://www.akademie-heidelberg.de/seminar/das-betaeubungsmittelrecht-im-beruflichen-alltag
02/10/2014 – 05/04/2017 Idstein, Germany
PHARMACY TECHNICIAN Hochschule Fresenius University of Applied Sciences
Address Limburger Str. , 65510, Idstein, Germany Website https://www.hs-fresenius.de/
02/09/2012 – 01/10/2014 Friedrichshafen, Germany
BACHELOR OF ARTS Zeppelin Universität Friedrichshafen
Address Am Seemooser Horn 20, 88045, Friedrichshafen, Germany Website https://www.zu.de/
Field of study Corporate Management & Economics
01/06/2012 – 15/08/2012 New York City, United States
ENTREPRENEURSHIP CERTIFICATE NFTE network for teaching entrepreneurship
Address 120 Wall Street, 18th Floor New York, NY 10005 , New York City, United States
Website https://www.nfte.com/programs/
Get To Know The Companies I Worked With
CureVac (CureVac Real Estate GmbH)
Sanofi-Aventis (Sanofi-Aventis Germany GmbH)
Canopy Growth (Canopy Growth Germany GmbH)
symbolic image of cannabis production facility - not specific to Canopy Growth
Metropolitan Pharmacy
symbolic image of a pharmacy - not specific to Metropolitan Pharmacy
symbolic image of an mRNA vaccine - not specific to CureVac
symbolic image of Sanofi - not specific to Sanofi-Aventis
Charité Universitätsmedizin Berlin
symbolic image of a clean room facility - not specific to Charité Universitätsmedizin Berlin
"Mr. Povel's excellent interdisciplinary proficiency in Project Management provided the strategic support to shape the overall portfolio and roadmap for customer functions, enablers, as well as hardware and digital services."
Lucia Pabon Global Portfolio Manager