- 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.
- 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
-
Quality Assurance
vor 1 Woche
ZL Microdent-Attachment GmbH & Co. KG DeutschlandQuality Assurance/Regulatory Affairs & GC Quality Management Manager (m/w/d) in Breckerfeld Die GC Corporation wurde 1921 in Japan gegründet und hat sich zu einem der führenden Unternehmen in der Entwicklung, Herstellung und dem Vertrieb einer sehr breiten Palette von Dentalprodu ...
-
Manager Quality Assurance
vor 6 Tagen
Avextra Pharma GmbH Deutschland GanztagsUnser Standort in Bensheim ist die zentrale Schnittstelle für die Planung, Umsetzung und Kontrolle unserer Pharmaproduktion. Gemeinsam verantwortet das QM-Team die GMP-Konformität unserer Produkte und ist Ansprechpartner für unseren Kunden und Lieferanten zu qualitätsrelevanten F ...
-
Manager Quality Assurance
vor 4 Tagen
Biosensors International Group, Ltd DeutschlandWir suchen einen hochqualifizierten und motivierten QA Manager, der sich unserem dynamischen Team (vor Ort in Hechingen) in der Medizintechnikbranche anschließt. In dieser Position spielen Sie eine entscheidende Rolle bei der Sicherstellung höchster Qualitätsstandards, insbesonde ...
-
Quality Assurance Tester
vor 1 Woche
TRYBER (by UNGUESS) Deutschland· WICHTIG · Um sofort dein Konto bei TRYBER zu erstellen und mit deiner Tätigkeit als QA Tester Geld zu verdienen, gehe zum folgenden Link: · Wir sind TRYBER , die Crowdtesting-Plattform von UNGUESS · Wir haben es uns zur Aufgabe gemacht, die digitale Welt durch die Unte ...
-
HEAD OF QUALITY ASSURANCE
vor 4 Tagen
MiP Pharma DeutschlandPharma ist Zukunft · Die MiP Pharma Unternehmensgruppe ist ein international aufgestelltes mittelständisches Pharmaunternehmen mit Sitz, Entwicklung und auch Produktion in Deutschland. Mit unserem 270-köpfigen Team leisten wir einen zuverlässigen und nachhaltigen Beitrag zur Arz ...
-
Supplier Quality Assurance Engineer
vor 5 Tagen
HOPPECKE Systemtechnik GmbH DeutschlandVoll/Teilzeit · Als größter europäischer Hersteller von Industriebatteriesystemen in privater Hand gestalten wir seit 1927 die Zukunft der Energiebranche mit und sind stolz auf das, was wir von hier aus geschafft haben: Unternehmerische Höchstleistungen als globaler Systemanbiet ...
-
ORBIT Gesellschaft für Applikations- und Informationssysteme mbH DeutschlandConsultant Quality Assurance and Regulatory Affairs (m/w/d) Deine Aufgaben Du unterstützt unsere Kunden bei der Vorbereitung der Konformität im Rahmen der Einführung und des Betriebs von KI-Systemen. Dabei berätst du umfassend aus methodischer Sicht zu Safety Assurance Cases und ...
-
Quality Assurance Engineer
vor 4 Tagen
Next Ventures DeutschlandQA / Quality Assurance Engineer | Mannheim | SaaS AI Supply Chain · QA Engineers with 3+ years of experience this one for you · Our client, a hyper-scale-up superpower in the Supply chain realm, is looking to bring on new QA Engineers to help support the introduction of a new Te ...
-
Quality Assurance Engineer
vor 1 Tag
microTECH Global LTD DeutschlandQuality Assurance Engineer - Power Semiconductors · Germany, Dusseldorf - Hybrid working · Our client is a fast growing semiconductor manufacturer focussed on the Automotive market segment. · Responsibilities: · • Product investigation by usage of various equipment · • Inves ...
-
Quality Assurance Manager
vor 1 Tag
Proclinical Staffing-PJP DeutschlandProclinical is seeking a dedicated Quality Management Specialist. The successful candidate will be responsible for maintaining and developing internal Quality Management System (QMS), conducting training for employees and will act as the central contact for all internal and exter ...
-
Quality Assurance Engineer
vor 4 Tagen
European Recruitment DeutschlandJoin a prominent Semiconductor leader and manufacturer of Electronic Components in a Quality Assurance position. Bring your meticulous attention to detail and passion for excellence to ensure our products meet the highest standards. Thrive in a dynamic environment where your cont ...
-
Quality and Assurance Engineer
vor 1 Tag
microTECH Global LTD DeutschlandQuality Assurance Engineer - Power Semiconductors Germany, Dusseldorf - Hybrid working · Our client is a fast growing semiconductor manufacturer focussed on the Automotive market segment. · Usage of automotive quality tools, like 8D report · • Support customers product qualifi ...
-
Senior Quality Assurance
vor 1 Woche
Open Talent Deutschland000 + bonus / Trading Fintech / Remote / Berlin · Join a Product Focused Trading Fintech seeking a strong Lead Quality Assurance Engineer · This position allows QA Leads to enter the field of Quantitative Analysis within Trading as the company is seeking to further strengthen th ...
-
Biosensors International Group, Ltd DeutschlandWir suchen einen hochqualifizierten und motivierten QA Manager, der sich unserem dynamischen Team (vor Ort in Hechingen) in der Medizintechnikbranche anschließt. In dieser Position spielen Sie eine entscheidende Rolle bei der Sicherstellung höchster Qualitätsstandards, insbesonde ...
-
Senior Director Quality Assurance
vor 1 Tag
BioTalent DeutschlandSenior QA Director - Bavaria · BioTalent is currently supporting a leading global pharmaceutical organisation that are seeking a highly motivated and experienced QA Director. As the Senior QA Director, you will play a pivotal role in coordinating the QA and QP organisation throu ...
-
Senior Quality Assurance Engineer
vor 1 Woche
TIS (Treasury Intelligence Solutions) DeutschlandWe are looking for an employee based in Germany, Belgium, or Bulgaria to strengthen our remote team. · Actively participate in all stages of the software development lifecycle to proactively identify and address quality issues early in the process. · Develop and execute test pl ...
-
Automation Quality Assurance Engineer
vor 2 Wochen
Foxy DeutschlandVC-backed AI Companion startup seeking talented QA Engineer. Flexible, fully-remote, fast-paced teams are your vibe #128168; · ai is a cutting-edge AI platform that partners with influencers and celebrities to allow users to chat, call, and exchange pictures with them 24/7 in any ...
-
LCV EUCOM EW Germany: Associate Quality Assurance Specialist
vor 22 Stunden
KBR Germany, Deutschland Paid WorkTitle: · LCV EUCOM EW Germany: Associate Quality Assurance Specialist · Program Summary · KBR leads the government services world contingency market by providing responsive, full-service logistics support to forces deployed around the world under the Logistics Civil Augmentation ...
-
Consultant (m/w/d) Microsoft
vor 3 Tagen
ORBIT Gesellschaft für Applikations- und Informationssysteme mbH DeutschlandConsultant Quality Assurance and Regulatory Affairs (m/w/d) Deine Aufgaben Du unterstützt unsere Kunden bei der Vorbereitung der Konformität im Rahmen der Einführung und des Betriebs von KI-Systemen. Dein Profil Du verfügst über ein abgeschlossenes Studium im Bereich Informatik o ...
-
EPI Europrop International GmbH deutschland, DeutschlandDie EPI Europrop International GmbH ist von der Airbus Military S. L. mit der Konzipierung, Ent-wicklung, Fertigung, Lieferung und logistischen Unterstû¥tzung der TP400-D6 Triebwerke fû¥r das A400M Flugzeug beauftragt. Das Unternehmen mit Hauptsitz in Mû¥nchen wurde im Jahr 2002 ...
Director of Quality Assurance - Germany, Deutschland - WuXi AppTec
Beschreibung
(Senior) Director of Quality Assurance (STA Qualified Person (QP))
Location: Germany, Munich, but willingness to travel and stay at WuXi STA Couvet, Switzerland site.
Location: Germany, Munich, but willingness to travel and stay at WuXi STA Couvet, Switzerland site.
&v=024){kind=logo}
