(Senior) Director of Quality Assurance (STA Qualified Person (QP)

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 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 training. Coach staff 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 a regulated pharmaceutical environment; more than 6 years of 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, in cross-functional and self-directed work teams.

#J-18808-Ljbffr