About Quality Risk Management Associates, LLC

Quality Risk Management Associates provides expert quality risk management, quality assurance and regulatory compliance support to the pharmaceutical and biotechnology industries around the world. With broad expertise in all phases of pharmaceutical development- from R&D through distribution and associated regulations focused on GxP, Quality Risk Management Associates ensures regulatory compliance and minimizes risk across the clinical development process.

Quality Risk Management Associates have demonstrated the ability to strengthen an organization by proactively accelerating risk identification and detection and resolving issues before they manifest as real problems. This has been accomplished by successfully transforming traditional auditing methods by spearheading innovative quality risk management and compliance systems and driving new governance and control standards that help business partners proactively identify, manage, and mitigate risk. Collaborating closely with Clinical Research, Medical Affairs and Safety personnel and working with business partners and regulators, we have created an environment that promotes risk awareness and elevates risk mitigation while focusing on customer needs aimed to improve overall compliance while ensuring confidence of data leading to safe and efficient delivery of medicines/products to patients.

Achievement highlights include development of quality risk management and mitigation models, tools and information management systems utilizing Six Sigma techniques, process optimization (Operational Excellence & LEAN techniques), quality by design, elevated quality management efficiency and process auditing approaches through sound risk-based strategies.

Quality Risk Management Associates provides over 10 years of leadership and management experience including training, developing, mentoring in quality assurance/regulatory compliance in a GxP environment and inspiring highly effective quality management staff and teams by harboring superior work ethics and a commitment to excellence that optimizes measurable outcomes and leadership potential. Our innovative senior consultants have over two decades of quality assurance and quality management experience working in the pharmaceutical/biotechnology industries all with excellent analytical, problem-solving and conflict resolution skills.