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

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

Client: WuXi AppTec

Location: Germany, Munich, but willingness to travel and stay at WuXi STA Couvet, Switzerland site.

Job Category: Other

EU work permit required: Yes

Job Reference: f714e1db6a0c

Job Views: 8

Posted: 25.04.2025

Expiry Date: 09.06.2025

Job Description:

Overview

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

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. 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. 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 of people leadership and team management experience.
• More than 5 years in EU Qualified Person role, with necessary qualification and certification to act as EU Qualified Person.
• Excellent presentation and communication skills in German and English.
• Demonstrated 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 resource 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.