Manager, Quality Management Systems

• The Quality Management Systems Manager is responsible for the managing and maintenance of the Quality Management System. This includes day-to-day support, continuous improvement, and ensuring the consistent implementation of global quality system policies.

• Manages and adheres to Global Quality Management System (QMS) Identifies, triages, escalates and monitors quality issues and investigations across the organization. Elevates serious and/or systemic problems with appropriate recommendations/solutions to Senior Management for immediate and long-term resolution in accordance with Global procedures.

• Proactive ownership of global Quality System procedures (Standard Operating Procedures and Policies such as Change Control, Deviation, Corrective and Preventive Action, Document Management etc. Responsible for the timely completion global compliance, deviation, and CAPA commitments.

• Collaborate with local and global Quality teams to ensure adherence and alignment to global policies, processes and practices. Support the implementation of a single harmonized Quality approach across divisions.

• Responsible for ensuring that the quality management system drives global regulatory compliance, is scalable and appropriate for the organization and product portfolio. Ensures consistency in implementation of global processes, CAPAs, and inspection responses. Manage key quality system projects driving alignment at all levels of the organization

• Experience with drug development and/or commercial Quality systems focused on the development, manufacture and delivery of small molecule, biologic and advanced (gene) therapy IMP. Leads risk assessment and mitigation activities to establish and improve the Quality Management System. The candidate works cross functionally to align the approach to quality and compliance across the global organization.

• Expertise in the areas of responsibility with technical and personnel leadership qualities, including GxP acumen aligned with industry best practices. Partners with clinical and/or commercial operations and across organization to streamline and continuously improve Quality systems, ensuring compliance with regulatory requirements.

• As needed, partner to support audits and inspections with the goal of compliance to regulations and global harmonization. Support identification and implementation of new regulations and Quality trends within the Pharmaceutical industry through literature review, professional conferences, and benchmarking organizations.