Work Schedule
Standard Office Hours (40/wk)
Environmental Conditions
Office
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%).
