Beschreibung
Gesucht: Clinical Quality Assurance (m/w/d) in ArbeitnehmerüberlassungIhre Aufgaben in Clinical Quality Assurance (m/w/d)
Proactively oversee the Clinical Quality Risk Management process and submission/inspection readiness activities and ensure that processes are under control.
Provide robust quality oversight in the following areas of clinical development:
- Proactively support / collaborate with key stakeholders to ensure that risks are identified, regularly reviewed, communicated and controlled.
- Support deviation/incident management for deviations pertinent to the programs being assigned and collaborate with other QA teams and business to drive continuous im-provement.
- Provide regulatory intelligence guidance to day to day questions arising from Clinical tri-als deliverables
- Participate in review and approval of key Clinical Study documents (e.g., Study Protocols, Monitoring Plans and Clinical Study Reports).
- Collaborate with other QA functions and business to drive outsourced activities
- Support inspection management (preparation, hosting, follow-up) in collaboration with other QA groups and business functions.
- Support audit planning, management and follow-up
Support development and implementation of Quality Management Systems at global and local level, as applicable.
Ihr Profil
- Bachelor Degree in LifeSciences, PharmacyorMedicines
- Fluent in English, knowledge of other languages (e.g., German) a plus but not required
- Minimum 6 years of experience in regulated activities (GCP/PV), clinical development and/or QA positions
- Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development
- Ability to work independently and in a global/matrix environment
- Two or more years' experience in managing projects
- Ability to effectively interact with and present to senior management, as well as to external audiences and inspectors
- Strong skills in GCP, quality and/or clinical development; Experience in Late Phase Clinical Development desirable
- Experience with managing Authority inspections desirable
- Auditing Experience desirable
- Strong interpersonal, communication, negotiation, and problem solving skills.
Rahmendaten
- Projektstart: ab sofort
- Projektdauer: 4 Monate, in Arbeitnehmerüberlassung
- Einsatzort: Holzkirchen
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