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

white and blue labeled bottlewhite and blue labeled bottle
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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

a man in a lab coata man in a lab coat

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."

A person wearing a white lab coat, safety goggles, and a protective mask is holding a transparent well plate filled with blue liquid under a bright light. The person is also wearing purple gloves.
A person wearing a white lab coat, safety goggles, and a protective mask is holding a transparent well plate filled with blue liquid under a bright light. The person is also wearing purple gloves.
Two rectangular packages of Pharma Hemp products are placed on a granite surface. The top box is labeled as 'All Natural Hemp Oil' with 850mg indicated, in a blue and white color scheme. The bottom box is labeled 'Pharma Hemp Complex' with 2500mg, featuring a gold and white color scheme. Both packages include text detailing their approximate weight and percentage.
Two rectangular packages of Pharma Hemp products are placed on a granite surface. The top box is labeled as 'All Natural Hemp Oil' with 850mg indicated, in a blue and white color scheme. The bottom box is labeled 'Pharma Hemp Complex' with 2500mg, featuring a gold and white color scheme. Both packages include text detailing their approximate weight and percentage.

Lucia Pabon Global Portfolio Manager