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Senior Quality Assurance Manager, Systems and Compliance

vor 2 Monaten


Basel, Basel-Stadt, Schweiz Roche Vollzeit
About the Role

We are seeking a highly experienced and skilled Senior Quality Assurance Manager to lead our Quality Systems and Compliance team at our Basel Drug Substance Manufacturing site. As a key member of our Quality organization, you will be responsible for ensuring regulatory compliance and providing strategic direction for regulatory inspections and internal/external audits.

Key Responsibilities
  • Provide strategic direction for regulatory inspections, internal and external audits
  • Ensure regulatory compliance with the Pharma Quality Systems at the Roche Pharma Site Basel Drug Substance Manufacturing
  • Develop and implement the Learning Roadmap at Basel DS Manufacturing and learning initiatives
  • Ongoing review of quality assurance related processes and potential for improvement with a strong focus on lean management, fostering the development and implementation of new technologies
  • Set, monitor and correct performance in all Key Performance Indicators established
  • Balance requirements across own and other VSs Quality, remove barriers within and across Quality Teams
  • People leadership in accordance with the Roche People Practices from talent selection through talent development, coaching, capability building, change management and transformation with a focus on empowering decision making at the lowest possible level in self-directed teams
  • Accountable for Health Authority inspections
  • Budget responsibility for the respective Quality Team
  • Collaborating with the Quality & Learning network
Requirements
  • Graduate or higher level degree in life sciences, chemistry or pharmaceutical sciences with 10 or more years work experience in the pharmaceutical or related industry
  • 4 or more years in quality, compliance or other relevant experience in the pharmaceutical industry
  • Significant experience of Quality System principles, practices and standards for the pharmaceutical industry
  • Significant experience with audit and inspection management
  • Strong creative leadership skills according to the Visionary, Architect, Catalyst, Coach (VACC) model
  • Organizational change management expertise
  • Lean mindset and end-to-end thinker with a focus on continuous improvement. Ability to implement, coach and apply lean and agile ways of working
  • Ability to deliver at a high level in an environment that exhibits significant ambiguity
  • Outstanding communication skills, at both a global and local level, to include presenting to regulatory authorities and senior management as needed
About Roche

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.