Head of Global GxP Quality Systems — Sobi
- Location
- Basel
- Contract
- full-time
- Posted
- Yesterday
Role overview
The Global GxP Quality Systems Head is accountable for working collaboratively across the organization (at global and local level) to develop and implement of an enterprise-wide Quality and Compliance strategy covering end-to-end regulated processes conducted by Sobi functions, Affiliates, service providers and partners to assure adherence to global health authority requirements across the product lifecycle.
Key responsibilities
- Leading Global GxP Compliance & Quality Systems team
- Responsible for advancing a Quality &Compliance Excellence mind set and has a unique opportunity to lead transformational change to a culture of excellence and working across the Global Quality organization to streamline and simplify by taking an end-to-end integrated approach to quality and compliance across the product lifecycle
- Responsible for the effectiveness and sustainability of Global Sobi Quality Management System at global and local level
- Responsible to oversee the quality system and ensure compliance with current GxP and regulatory requirements
- Responsible to establish and maintain budget and timelines as well as supervise the implementation and maintenance of quality relevant processes
- Responsible to provide leadership and strategic direction to teams working within GxP relevant activities to ensure adherence to the principles and processes of the quality strategy and take actions where needed to ensure company wide compliance
- Responsible to oversee of quality relevant processes, and in conjunction with the Global Process Owners identify areas of improvement and implement steps to improve them with a continuous focus on improving strategies and tools
- Responsible for the development, implementation and sustainability of risk management process for timely identification and reporting of risks to maintain a concept of Quality Risk Management
- Accountable for the definition and approval of Annual Audit Programs and preparation, conduction/host and follow up of internal audits and regulatory inspections
- Key responsibilities:
- Leading Global GxP Compliance & Quality Systems team
Main responsibilities
- Key responsibilities:
- Leading Global GxP Compliance & Quality Systems team
Company and context
- The Global GxP Quality Systems Head is accountable for working collaboratively across the organization (at global and local level) to develop and implement of an enterprise-wide Quality and Compliance strategy covering end-to-end regulated processes conducted by Sobi functions, Affiliates, service providers and partners to assure adherence to global health authority requirements across the product lifecycle.
- Responsible for advancing a Quality Excellence mind set and has a unique opportunity to lead transformational change to a culture of excellence and working across the Global Quality organization to streamline and simplify by taking an end-to-end integrated approach to quality and compliance across the product lifecycle
- Responsible for the effectiveness and sustainability of Global Sobi Quality Management System at global and local level
- Responsible to oversee the quality system and ensure compliance with current GxP and regulatory requirements
- Responsible to establish and maintain budget and timelines as well as supervise the implementation and maintenance of quality relevant processes
- Responsible to provide leadership and strategic direction to teams working within GxP relevant activities to ensure adherence to the principles and processes of the quality strategy and take actions where needed to ensure company wide compliance
- Responsible to oversee of quality relevant processes, and in conjunction with the Global Process Owners identify areas of improvement and implement steps to improve them with a continuous focus on improving strategies and tools
- Responsible for the development, implementation and sustainability of risk management process for timely identification and reporting of risks to maintain a concept of Quality Risk Management
- Accountable for the definition and approval of Annual Audit Programs and preparation, conduction/host and follow up of internal audits and regulatory inspections
- Responsible to provide strategic direction and report performance of the quality system and related procedures to Sobi Senior Leaders Officer on a regular basis and initiate preventive and corrective actions to avoid recurrence of deviations/non-conformances
Additional details
- Minimum 15 years' experience from pharmaceutical industry within global Quality system, Quality, Manufacturing, Product development and/or Regulatory affairs Minimum 10 years leadership experience
- Experience from working in an international organization and across borders Strong in leadership and communication
- Culture awareness and understanding the way of behavior in different cultures Holistic business understanding Courage, empathy, trust, motivation
Notes and original content
- Minimum 15 years' experience from pharmaceutical industry within global Quality system, Quality, Manufacturing, Product development and/or Regulatory affairs
- Minimum 10 years leadership experience
- Experience from working in an international organization and across borders
- Strong in leadership and communication
- Culture awareness and understanding the way of behavior in different cultures
- Holistic business understanding
- Courage, empathy, trust, motivation
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.
