(Senior) Director of Quality Assurance
vor 5 Monaten
Overview
(Senior) Director of Quality Assurance (STA Qualified Person (QP))
Location: Germany, Munich, but willingness to travel and stay at WuXi STA Couvet, Switzerland site.
Responsibilities
Coordinate WuXi STA’s QP organization based in Germany Set up WuXi STA’s QP office and hold ownership of the related systems and processes. Be responsible for QP certification of WuXi STA’s manufactured products on behalf of clients for clinical and commercial products. Provide quality and compliance guidance to STA staff and sites. Assist in quality issue resolution in a timely manner to ensure smooth progress of projects. Drive quality improvement projects and continuous improvement. Host regulatory inspections to obtain necessary licenses and authorizations to support QP review and certification processes. Host major client audits related to STA QP organization and ensure successful completion of these audits. Properly allocate resources to all projects and activities. And make adjustments whenever is needed, ensuring that every project meets timeline and Quality requirements. When significant quality impact of a project is identified, immediately report to upper management and communicate with the customers (including proposal for solution and prevention). Communicate with the customer in a timely manner and ensure customer satisfaction. Meet customer requirements by understanding the customer needs. Communicate across STA organization and sites to assure QP processes and certification. Recruit new staff and ensure that they receive proper and adequate trainings. Coach staffs so that they continuously improve their work skills.
Qualifications
PhD/Master in pharmaceutical, chemical or analytical sciences or equivalent degree. Be proficient in drug product manufacturing processes, support and GMP regulations. More than 10 years experience in Quality Assurance or other relevant functions in regulated pharmaceutical environment; more than 6 years people leadership and team management experience. More than 5 years in EU Qualified Person role, necessary qualification and certification to act as EU Qualified Person Excellent in presentation and communication in German and English Demonstrate ability in problem solving, communications, quality system implementation and team building. Demonstrated ability of pro-active thinking and setting up systems for prevention of quality issues Demonstrate outstanding and balanced participative/directive and quality leadership. A talent for fostering resources optimization, continuous improvement and operational efficiency. Exceptional skills for analyzing problems and finding innovative solutions. Proven ability to motivate, mentor and work efficiently, as well as with persons from other cultures, as in cross-functional and self-directed work teamsLocation: Germany, Munich, but willingness to travel and stay at WuXi STA Couvet, Switzerland site.
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