Frank Gunson
Accomplished Quality Professional | Project Management Expert | Regulatory Compliance Specialist | Servant Leader at Heart
- Role
- Vice President, Regulatory Affairs & Patient Safety at McKesson
- Location
- Chester Springs, PA, US
- LinkedIn followers
- 500 followers
About Frank Gunson
Dynamic quality management leader in the pharmaceutical industry with experience in quality management, regulatory compliance, and project leadership. Known for driving operational excellence, promoting cross-functional collaboration, and upholding regulatory standards in diverse global settings. Demonstrated success in delivering cost savings, spearheading process enhancements, and designing quality initiatives to align with strategic goals and regulatory requirements.
Experience
Vice President, Regulatory Affairs & Patient Safety
Dec 2024 — Present
Strategic Leadership in Regulatory Affairs: Establishing enterprise-level strategies and governance to ensure compliance with FDA, Health Canada, and other global regulatory bodies, enhancing McKesson\'s reputation as a leader in safe product distribution.Collaborative Stakeholder Engagement: Successfully partnering with legal, compliance, and quality teams to identify and mitigate regulatory risks, implementing scalable solutions that consistently exceed compliance requirements and foster a cohesive approach across the organization.Regulatory Reporting Excellence: Developing and standardizing enterprise-wide reporting processes, ensuring accuracy and timeliness in submissions to regulatory agencies, while driving improvements in reporting.Innovative Risk Mitigation & Training: Exploring cutting-edge technology for proactive regulatory monitoring and developing comprehensive training programs, cultivating a culture of regulatory awareness and adaptability within McKesson, empowering employees to navigate the evolving regulatory landscape with confidence.
Education
Cambridge College Global – NEIB
Master of Science - MS, Quality Systems Management
Delaware Valley University
Bachelor's degree, Biology, General
Skills
- U.s. Food and Drug Administration (Fda)
- Glp
- Pharmaceutics
- Good Laboratory Practice (Glp)
- Root Cause Analysis
- Formulation
- Capa
- Gmp
- CRO
- Pharmaceutical Industry
- Deviation Management
- Fda
- Ind
- Drug Development
- Toxicology
- Corrective and Preventive Action (Capa)
- Operational Efficiency
- Clinical Development
- Project Management
- Sop Authoring
- Pre-Clinical Studies
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