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.
Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/