Today’s emerging life sciences organization operates much differently than a start-up in the early 2000’s. As pointed out in a recent McKinsey article, pharmaceutical companies are under significant pressure as part of a maturing industry, to both innovate and successfully manage increasingly complex operations, more stringent regulatory requirements and frequent consolidations. In this context, the role of the quality assurance (QA) executive has expanded beyond post-approval activities such as CAPA, supplier evaluation and audit management. Many of the QA executives we have talked to have these responsibilities: Analyze Clinical Trial Data to Assure Quality and Determine Feasibility: QA professionals are being asked to be part of the executive team that analyzes clinical trial data to determine the most valuable opportunities for treatment and business growth. Collecting Accurate and Timely Production Data: Tracking global suppliers and CMOs from acceptance of raw materials to predicting potential batch results issues is critical. Gaining Visibility into Governance, Risk and Compliance (GRC) issues and Data Integrity Behavior: Monitoring risks associated with third-party… ...

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