As the Vice President of Quality at Tyra Biosciences, Gary P. plays a pivotal role in shaping the strategic direction of the Quality department within a dynamic and rapidly evolving early-phase drug development organization. With a robust background in quality and regulatory compliance, Gary is...
As the Vice President of Quality at Tyra Biosciences, Gary P. plays a pivotal role in shaping the strategic direction of the Quality department within a dynamic and rapidly evolving early-phase drug development organization. With a robust background in quality and regulatory compliance, Gary is dedicated to fostering a culture where compliance is seamlessly integrated into everyday practices. His leadership is characterized by a collaborative approach, engaging all levels of the organization to identify challenges and implement effective solutions that make adherence to regulatory standards second nature.
Under Gary's guidance, Tyra Biosciences is advancing its Quality Management System (QMS) to ensure compliance with critical regulations, including 21 CFR Part 11. He is actively involved in the identification and implementation of systems that enhance operational efficiency while maintaining rigorous quality standards. His expertise in FDA regulations, cGMP, and quality auditing is instrumental in navigating the complexities of the pharmaceutical and biotechnology landscapes, particularly during technology transfers and FDA inspections.
Gary's commitment to building a robust quality framework is evident in his strategic oversight of budgeting and headcount, ensuring that the Quality department is well-equipped to support the organization's growth. His passion for regulatory compliance not only drives the success of Tyra Biosciences but also positions the company as a leader in the industry, committed to delivering safe and effective therapies. Through his vision and expertise, Gary P. is not just ensuring compliance; he is transforming it into a core value that propels the organization forward.