Joshua Gundolf serves as the Director of Quality at SCA Pharmaceuticals, where he plays a pivotal role in ensuring that the organization meets the highest standards of quality and compliance within the highly regulated pharmaceutical industry. With over a decade of extensive experience in US-FDA...
Joshua Gundolf serves as the Director of Quality at SCA Pharmaceuticals, where he plays a pivotal role in ensuring that the organization meets the highest standards of quality and compliance within the highly regulated pharmaceutical industry. With over a decade of extensive experience in US-FDA regulated environments, Joshua has cultivated a robust expertise in Good Manufacturing Practices (cGMP), particularly in the context of 503B outsourcing and plasma-derived medicines. His hands-on approach to quality operations has been instrumental in driving process improvements and enhancing product quality across the organization.
As a key member of the SCA Pharma Site Leadership team in Little Rock, Joshua has successfully navigated multiple regulatory compliance inspections, including those conducted by the US-FDA and various State Boards of Pharmacy. His leadership during these inspections has not only ensured compliance but also strengthened the organization’s reputation among prominent customers and Group Purchasing Organizations (GPOs) in the 503B space.
In addition to his regulatory accomplishments, Joshua spearheaded a cross-functional Quality Event Team that achieved a significant reduction in deviation initiation within just six months. This initiative exemplifies his commitment to continuous improvement and operational excellence. His skills in root cause analysis, internal auditing, and change management have been crucial in fostering a culture of quality and accountability throughout the organization. With a strong foundation in quality systems and documentation, Joshua Gundolf is dedicated to advancing SCA Pharmaceuticals' mission of delivering safe and effective pharmaceutical products while maintaining the highest standards of quality assurance.
