In this episode of "The Emerging Biotech Leader" podcast, host Ramin Frahood speaks with Helen Kargaryani, VP Global Head of Quality/Quality Services at SSI Strategy. With over 30 years of experience in the pharmaceutical and biotech industries, Helen shares her expertise on quality and risk management.
Risk management in these industries is a critical process that helps companies identify, prioritize, and mitigate potential issues affecting their operations, compliance, and financial stability. "Quality is the ultimate goal” Helen explains. “A Quality Management System maintains quality, while risk assessment helps us identify and mitigate risks to quality. Together, these three elements build a solid platform for compliance in the company."
The approach varies between organizations based on their specific business, stakeholders, and patients served.
Key Takeaways:
Proactive risk management is essential for biotech and pharma companies: It helps avoid regulatory issues and financial losses, working in tandem with quality management systems (QMS) to ensure effective compliance.
Risk management should be tailored and integrated: Strategies need to be customized to a company's size, resources, and specific needs. Importantly, risk management should be integrated into company-wide strategy and culture, not isolated to a single department.
Common pitfalls in risk management can have severe consequences: Many companies fail by either not including risk management in strategic planning or not implementing it effectively. This can lead to regulatory non-compliance, financial losses, and potential product shortages affecting patients.
Early implementation is crucial, especially for startups and small biotech firms: Even with limited resources, companies should start implementing risk management early on a small scale, ensuring their approach is scalable as they grow.
This episode provides valuable insights into the critical role of quality and risk management in the biotech and pharmaceutical industries, based on Helen’s extensive professional experience and perspective.
If you'd like to discuss how you might apply these learnings to your own context, contact us at
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