Head of Global GxP Quality System and Compliance

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases.

As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.

We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.

Job Description

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
• 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

Qualifications

• Master degree in pharmacy or other relevant degree (Engineering, Chemistry or alike)
• Minimum 15 years' experience from pharmaceutical industry within global Quality system, Quality, Manufacturing, Product development and/or Regulatory affairs
• Minimum 10 years leadership experience
• Pharmaceutical and medical device business understanding including in-depth knowledge about regulatory and GMP requirements, and experienced in GCP and GVP regulations
• Experience from working with improving business practices/working procedures
• Strong experience of working in virtual pharma company set-up and in digitalization for QMS (e.g Veeva or other global systems)
• Understanding of the pharmaceutical market interrelations and implications
• Experienced in working with high impact stakeholders, e.g. authorities, strategic business partners Experience from setting up and working with performance management, KPIs, including the management cycle
• Experience from working in an international organization and across borders
• Strong in leadership and communication
• Proactive mindset and actions, Strong interpersonal and collaboration skills, 
• Result oriented, and able to solve complex situations and problems, as well as handle conflicts and create win-win situations
• Culture awareness and understanding the way of behavior in different cultures
• Holistic business understanding
• Courage, empathy, trust, motivation
   

Additional Information

Si vous souhaitez mettre votre enthousiasme au service d’un acteur dynamique de la santé en mouvement, retrouvez cette offre sur Open positions | Sobi