The FDA Group's CEO Nick Capman, sits down with David Marks to discuss the intricacies of Quality culture and QA communication pathways in the life sciences. David is a strategic advisor and experienced executive with a proven track record in establishing global Quality, Operational, Corporate Stewardship, Change Management, and Integration programs across biopharma and CROs.
Discussion points include:
» The crucial role of a Quality culture, especially in biopharma and clinical settings. David discusses how a strong Quality culture leads to proactive organizations, reducing the frequency of audits and audit findings.
» The separation of Quality from Operations to prevent conflicts of interest, and the importance of a partnership between these departments for effective decision-making and communication.
» The responsibility of leaders in cultivating a culture of Quality, and how leaders should actively demonstrate and reinforce Quality values within the organization to build trust and openness.
» The business case for Quality culture, and how it's more efficient and cost-effective to do things right the first time. David advises Operations to approach Quality issues without fear or ego, fostering open discussions.
» How investing in Quality as a crucial preventive measure saves money and avoids future issues, particularly vital in life sciences.
» Encouraging informal, trust-building discussions between QA and Operations. He stresses the importance of QA being approachable and open to discussions, which leads to significant organizational improvements.
» A shift towards more open communication in modern Quality cultures. He highlights the importance of mechanisms for employees to ask questions anonymously in environments where fear or ego might be present.
» The often-overlooked human element in Quality culture, underscoring the need for personal relationships, understanding, and cooperation between Quality and Operations teams.
» The tangible benefits of a strong quality culture, such as improved efficiency, reduced costs, and enhanced organizational maturity.
David is a distinguished executive in the bio-pharma and CRO industries, known for his strategic expertise in global Quality, Operational, Corporate Stewardship, Change Management, and Integration programs. His career spans leading and supporting Cross-Functional Strategic Partnerships, GxP Quality Assurance/Management Operations, and Sustainability/ESG initiatives.
He has a proven track record of hands-on leadership and program oversight across North America, Latin America, Europe, and Asia-Pacific, demonstrating his ability to navigate complex international environments. He is adept at managing high-level strategic initiatives and C-suite special assignments across multiple corporate divisions, showcasing his versatile leadership skills.
Additionally, as an Emeritus Registered Quality Assurance Professional in Good Clinical Practice (RQAP-GCP) from the Society of Quality Assurance (SQA), he brings a deep commitment to quality assurance and extensive knowledge in Good Clinical Practice. His contributions have significantly influenced organizational success and set benchmarks in quality and operational excellence in the bio-pharma and CRO sectors.