As a seasoned professional in quality assurance and regulatory compliance, I excel in the rigorous enforcement of standards critical to pharmaceutical manufacturing. My expertise spans comprehensive management of pharmaceutical labeling and in-depth auditing aligned with global regulatory requirements. With a career dedicated to enhancing product integrity and compliance, I have spearheaded numerous initiatives that have significantly advanced operational excellence.Driven by a keen attention to detail and a robust understanding of cGXP, GLP, and GDP practices, I have been pivotal in guiding cross-functional teams through complex regulatory landscapes, fostering collaboration that transcends departmental boundaries. My approach is strategic and analytical, always aimed at optimizing operational frameworks and achieving meticulous compliance across diverse projects. By prioritizing continuous improvement and innovative process solutions, I aim to uphold the highest standards of quality and efficiency, ensuring that all compliance efforts are not only met but surpassed. This dedication has positioned me as a leader in transforming practices and driving forward the strategic objectives necessary for success in demanding regulatory environments.
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Remote Cmc Qa Auditor | Lead AuditorMerck Oct 2022 - Dec 2023West Point, PennsylvaniaIn my role, I navigated the complexities of regulatory document review, ensuring precision and compliance across Biological Listing Applications, Vaccines, and New Drug Applications. I spearheaded CMC auditing projects, enhancing workflows and maintaining high standards through effective team and auditor coordination.• Successfully led cGXP CMC QA Audits, securing final approval for critical documents slated for global regulatory filings.• Collaborated with CMC authors to address and resolve audit findings, elevating document quality and compliance.• Conducted detailed audits of module sections ranging up to 175 pages, showcasing acute attention to regulatory details.• Fostered inter-departmental synergy, ensuring quality and compliance aligned with stringent industry standards. -
Gxp Influenza Virus ProductionSanofi Pasteur Oct 2020 - Aug 2022Swiftwater, PennsylvaniaDuring my tenure, I spearheaded updates to Process Development Records and SOPs tailored for the Swiftwater Campus, thereby refining procedural compliance. I collaborated closely with senior researchers to manage quality documentation essential for cGMP, GLP, and GDP adherence, ensuring readiness for regulatory inspections.• Managed and optimized production processes to adapt to business fluctuations, maintaining efficiency and compliance.• Trained new team members, ensuring thorough understanding and adherence to regulatory standards.• Contributed to CAPA initiatives, addressing safety and quality issues to enhance operational safety and process quality.• Led safety audits and participated in safety meetings to ensure a secure and compliant working environment.
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Senior Quality Assurance SpecialistEurofins Lancaster Laboratories 2019 - 2020Lancaster, PennsylvaniaIn this role, I was responsible for upholding and advancing quality standards within the laboratory setting, conducting rigorous audits and leading comprehensive training for departmental personnel to ensure alignment with updated regulatory standards.• Implemented and adhered to strict GMP, GLP, and CFR regulations, ensuring comprehensive compliance across all operations.• Served as a Subject Matter Expert, reviewing essential documentation and aligning laboratory practices with regulatory expectations.• Maintained rigorous control over laboratory standards, supporting the reliability and accuracy of testing procedures. -
Contract Services For Pharma And Food Packaging Labeling, Printing And ConvertingSelf Employed 2016 - 2018New York City Metropolitan AreaAs a consultant, I provided expert services for pharmaceutical and food packaging projects, focusing on compliance and quality assurance from design to production stages.• Partnered with clients to develop customized packaging solutions, responding adeptly to regulatory and market changes.• Applied advanced printing and converting technologies to deliver superior packaging that met stringent regulatory standards. -
Associate Director Regulatory Affairs - Labeling CompliancePar Pharmaceutical 2005 - 2015Chestnut Ridge, New YorkI led the Regulatory Affairs department, focusing on labeling compliance, managing staff, and coordinating across multiple departments to ensure alignment with global regulatory requirements and corporate objectives.• Developed and updated SOPs, keeping the department current with regulatory changes and best practices.• Oversaw labeling processes, ensuring accuracy and compliance from creation to production.• Managed cross-departmental collaborations, enhancing project integration and success across global operations.
Thomas Vogel Education Details
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Bachelor Of Science In Business Management
Frequently Asked Questions about Thomas Vogel
What is Thomas Vogel's role at the current company?
Thomas Vogel's current role is Quality & Compliance Champion | Pharmaceutical Auditing & Regulatory Expertise | Driving Operational Excellence & Compliance in Pharma.
What schools did Thomas Vogel attend?
Thomas Vogel attended University Of Phoenix.
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Thomas Vogel
New York City Metropolitan Area1virtusa.com3 +120145XXXXX
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Thomas Vogel
West Chester, Pa2ge.com, ge.com -
2optonline.net, ecu.edu
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