**Work Schedule** Standard Office Hours (40/wk) **Environmental Conditions** Office **Job Description** **Position Summary:** The Sr. Director leads the continuous development, deployment, and improvement of the global Quality Management System (QMS) that ensures a high state of cGMP compliance and supports the effective execution of PSG objectives. **Key Responsibilities:** + Develop, establish, improve, and maintain the global QMS elements, including policies, processes, procedures, and controls, enabling successful and efficient development and manufacturing of pharmaceutical products meeting customer and regulatory requirements. + Develop a robust system to assure corrective and preventive measures are systematically implemented and controlled. + Improve the efficiency of QMS leading simplification initiatives throughout the organization. + Develop relationships with professional organizations and practitioners to stay abreast with current Best Practices relevant to QMS. + Establish and maintain risk-based, fit-for-purpose Quality Management System (QMS) for PSG. + Develop, communicate, and ensure implementation of Quality Manual, Quality policies, standards, global procedures and processes across the PSG network. + Establish robust, comprehensive systems to assure corrective and preventive measures are implemented and controlled. + Lead the Communities of Practice effort to ensure all quality systems have a global owner who engages with SMEs throughout PSG. + Create on-going, robust systems to improve, simplify, and increase efficiency of PSG’s QMS. + Provide leadership, vision, and direction to the Global Quality Organization to create best in class Quality systems. + Lead the development and drive implementation of the PSG QMS strategy ensuring alignment with the broader Quality and PSG strategy. + Ensure proper governance and oversight of Quality systems and processes. + Establish Quality council framework and handle customer issues including. + Lead Quality integration efforts to ensure new or acquired sites are rapidly integrated and on-boarded to the PSG QMS. **Qualifications:** + B.S. Degree in business or a scientific/technical field required. Advanced degree desired. + Minimal 15 years experience in multinational pharma/biopharma organizations, covering multi-site quality systems, and quality operations roles with global experience. + Experience in strategy development and deployment, organisational change, and business improvement. + Strong people leader to engage and motivate a team of professionals. + Ability to travel frequently, including internationally (25 - 40%). Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.