Product Quality Leader (all genders)

at  Merck

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Product Quality Lead (PQL) is responsible for providing quality oversight of Pharma products/franchises throughout the product and design control lifecycle. Develops, approves, monitors, and maintains critical quality standards to proactively minimize product quality and design control risks. Ensures quality management of products and processes lifecycle, leading improvement, developing action plans related Product Quality health, and alignment with current regulatory expectations.

The individual will partner cross-functionally with various stakeholders e.g. Supply Network Operations, Manufacturing Sciences & Technology, Global Regulatory Affairs, Site Regulatory Compliance, Healthcare Quality, Global Pharma Manufacturing, as the Quality representative on relevant CMC boards to enable efficient communication and strategic decision making related to the quality of products.

• Provide quality oversight and strategic guidance throughout the CMC lifecycle management of Pharma drug substances and drug products
• Act as a Quality representative in cross-functional forums to provide support and oversight to internal manufacturing and testing facilities for application of PQS, throughout commercial lifecycle of products
• Serve as a single point of contact for the commercial products, responsible and accountable for overall success against the strategic plan (lifecycle, footprint, risks, business continuity)
• Responsible for commercial product scorecard incl. continuous monitoring, data analysis, reporting, and leveraging the PQS
• Provide quality support for significant changes and deviation and CPA management across internal manufacturing and testing facilities
• Coordinate deployment and application of controls supporting risk based continued process verification and monitoring of lifecycle product quality
• Ensure significant quality risks are escalated and mitigated in a timely manner
• In partnership with the Digital team(s), identify and implement tools to improve efficiencies of processes.