Senior Director of Quality Assurance STA Qualified person
vor 4 Wochen
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:
. Hold qualification and certification as QP in an EU member state
· 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 teams
· Location: Germany, Munich, but willingness to travel and stay at WuXi STA Couvet, Switzerland site.
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