Global Quality GVP Manager — Sobi
- Location
- Basel
- Contract
- full-time
- Posted
- 2 days ago
Role overview
The Global Quality GVP Manager mission is toensure quality oversight and quality assurance activities related to GVP area and guide and support from a quality perspective the global and local, as applicable, PV activities within Sobi
- The Global Quality GVP Manager mission is toensure quality oversight and quality assurance activities related to GVP area and guide and support from a quality perspective the global and local, as applicable, PV activities within Sobi
- Key responsibilities include in particular:
- Contribute to the development of the audit strategy & program and plans related to the GVP area-PV processes, vendors, Partners and affiliates
Main responsibilities
- Key responsibilities include in particular:
- Contribute to the development of the audit strategy & program and plans related to the GVP area-PV processes, vendors, Partners and affiliates
- Act as a GVP Audit Program Owner when delegated by Global Quality GCP/GVP Head
- Perform and coordinate PV audits internally and externally and act whenever needed as delegated by Global Quality GCP/GVP Head
- At least 5 year experience from the pharmaceutical industry with GVP responsibilities, and audit management and/or Quality Assurance experience
- Excellent knowhow of the EU/US/RoW regulations within GVP as well as Quality assurance activities principles and know-how
- Documented education/experience in QA systems and preferably auditing
- Structured approach with strong focus on results and highly detai-oriented orientation
- Strong interpersonal skills with communicative and flexible attitude
- Proactive and collaborative mindset with a strong multi-tasking abilities and a high resilience and adaptative skills
Company and context
- Support and collaborate with GPV organization and the safety interfaces such as Medical Affairs, Regulatory Affairs and Affiliates, as applicable
- Ensure qualification of global and local ESP, as applicable in GVP regulated area per Sobi procedures
- Act as QA representative in PV Inspections and different initiatives or projects as needed
- Ensure GVP Audits management excellence of the end-to-end audit management process and overview of the assigned audits, as planned
- Assess and approve from quality perspective the PV deviations (global and local, as applicable), PV related CAPAs.
- Prepare regular status report on performed audits, audit trending, PV deviation trending, PV CAPAs, trending and agreed upon metrics to ensure Quality oversight.
- Ensure the updates needed for audit related information to the PSMF and participate actively to the QPPV extended meeting.
- Contribute to the GVP audit strategy according to SOPs.
- Prepare GVP Audit annual plans according to SOPs, ensuring the risk assessment and prioritization of the GVP Audits are performed in collaboration with GPV organization and with GVP Audit program owner
- Authoring GVP QA related processes, review and approve the PV related SOPs (or SOPs from other RDMA and Quality areas with implicit or interfaced PV activities eg Medical information, regulatory, medical affairs, compassionate use)
Questions about this listing
What salary does Sobi offer for this role?
Sobi lists CHF 85'500 - 129'500 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 Sobi 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 Sobi 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 Sobi?
Use the "Apply now" button on this page — it links directly to Sobi's original listing at jobs.smartrecruiters.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
