GCP/GMP-Expertin/Experte (Translationale Regulatorik) — Universitätsspital Basel
- Location
- Basel
- Contract
- full-time
- Posted
- Yesterday
Role overview
Tasks
- Regulatory support of translational ATMP projects with focus on GCP/GMP-compliant clinical development
- Active communication between authorities and researchers to plan and implement the transition from preclinical development to first-in-human studies
- Coordination of interfaces between research, clinic, quality assurance and production of clinical investigational medicinal products
- Create, maintain and review SOPs and CTA/IMPD relevant documentation, ensure GCP compliance, quality-assured documentation and data integrity, including risk analysis, deviations and CAPA processing
Requirements
- Completed studies in life sciences, pharmacy, medicine or comparable experience
- Several years of experience in dealing with authorities and with GMP/GCP in the ATMP environment, ideally in the academic environment
- In-depth expertise in clinical trial processes, regulatory approvals and inspections as well as GCP/GMP quality management
- Excellent communication ability to manage interdisciplinary interfaces
- Structured and precise working methods, experience in project management as well as reliable knowledge of English and very good knowledge in one of the Swiss national languages (German preferred)
We offer
- Attractive wage policy and excellent social benefits
- Regulatory support of translational ATMP projects with focus on GCP/GMP-compliant clinical development
- Active communication between authorities and researchers to plan and implement the transition from preclinical development to first-in-human studies
Main responsibilities
- Regulatory support of translational ATMP projects with focus on GCP/GMP-compliant clinical development
- Active communication between authorities and researchers to plan and implement the transition from preclinical development to first-in-human studies
- Coordination of interfaces between research, clinic, quality assurance and production of clinical investigational medicinal products
- Create, maintain and review SOPs and CTA/IMPD relevant documentation, ensure GCP compliance, quality-assured documentation and data integrity, including risk analysis, deviations and CAPA processing Requirements
- Completed studies in life sciences, pharmacy, medicine or comparable experience
- Several years of experience in dealing with authorities and with GMP/GCP in the ATMP environment, ideally in the academic environment
- In-depth expertise in clinical trial processes, regulatory approvals and inspections as well as GCP/GMP quality management
- Excellent communication ability to manage interdisciplinary interfaces
- Structured and precise working methods, experience in project management as well as reliable knowledge of English and very good knowledge in one of the Swiss national languages (German preferred) We offer:
- Attractive wage policy and excellent social benefits
Additional details
- Create, maintain and review SOPs and CTA/IMPD relevant documentation, ensure GCP compliance, quality-assured documentation and data integrity, including risk analysis, deviations and CAPA processing
- Structured and precise working methods, experience in project management as well as reliable knowledge of English and very good knowledge in one of the Swiss national languages (German preferred)
- Campus in the heart of Basel and the Trinational Corner Comprehensive childcare facilities Free Sports and Exercise Program
Notes and original content
- Requirements
- Campus in the heart of Basel and the Trinational Corner
- Comprehensive childcare facilities
- Free Sports and Exercise Program
Questions about this listing
What salary does Universitätsspital Basel offer for this role?
Universitätsspital Basel lists CHF 62'000 - 94'000 gross per year for this position in Basel. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Universitätsspital Basel offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Universitätsspital Basel during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Basel?
EU/EFTA residents living in the border zone of the country adjoining Canton Basel can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Basel's cantonal migration office or with HR during the application.
How do I apply for this position at Universitätsspital Basel?
Use the "Apply now" button on this page — it links directly to Universitätsspital Basel's original listing at job.unispital-basel.ch, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
