Thomas Vogel Email & Phone Number

West Point, Pennsylvania

In 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.

Swiftwater, Pennsylvania

During 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.

Lancaster, Pennsylvania

In 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.

New York City Metropolitan Area

As 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.

Chestnut Ridge, New York

I 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.