Product Quality Leader (all genders)

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 productsAct 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 productsServe 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 PQSProvide quality support for significant changes and deviation and CPA management across internal manufacturing and testing facilitiesCoordinate deployment and application of controls supporting risk based continued process verification and monitoring of lifecycle product qualityEnsure significant quality risks are escalated and mitigated in a timely mannerIn partnership with the Digital team(s), identify and implement tools to improve efficiencies of processes. Who you are : Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 10 years at minimumWorking knowledge of relevant EU, China, and Japan regulations, MHRA, FDA, ICH standards / guidelines and experience in supporting successful regulatory inspections,Knowledge in design controls, risk management, and quality system requirementsWorking knowledge of control charts and statistics applied to process validation and data trending using statistical programs and softwareAbility to interact effectively with all levels of personnel within the organizationProven ability to lead and manage projects / teams of significant scope and complexity, while meeting all deliverables and timelinesExcellent interpersonal skills using a team oriented approach to project management and problem solving for complex issue resolution in a scientifically sound wayOutstanding communication skills (both verbal and written)Ability to navigate through ambiguity and rapid growth and adapt to changeAbility to be agile and effectively collaborate in a dynamic, cross-functional matrix environment