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RORoche Diagnostics Int. AG

Strategic Quality Partner - Assay and Reagents(m/w/x)

Risch-Rotkreuz
VollzeitVor OrtSenior

Partnering with Development Project Teams to accelerate milestones and deploy the D&D module. 8+ years in diagnostics industry experience required. Diverse and inclusive workplace, personal expression encouraged.

Anforderungen

  • Bachelor’s degree in science, business, or related field
  • MBA or advanced degree preferred
  • 8+ years experience in diagnostics industry or related business
  • Strong business/financial acumen
  • Enterprise mindset
  • Solid scientific/technical background with product knowledge
  • Infectious disease expertise preferred
  • Experience with regulatory requirements and submissions
  • FDA / FDA submissions experience
  • Knowledge of applicable standards and regulations
  • Demonstrated end-to-end experience
  • Strong decision-making capability
  • Pragmatic, solution-oriented mindset
  • Ability to operate without perfect information
  • Strong agile knowledge
  • Modern ways of working
  • Excellent communication skills
  • Excellent presentation skills
  • Excellent negotiation skills
  • Proven leadership experience
  • Leading cross-functional and global matrix teams
  • Driving change
  • Inspiring teams in line with Roche Values
  • Ability to influence globally
  • Deliver transformative, customer-focused solutions
  • Acting according to Roche Operating Principles
  • International travel as required

Aufgaben

  • Ensure effective partnerships with Development Project Teams
  • Accelerate project milestones and execution
  • Drive consistent interpretation and implementation of global requirements
  • Deploy and implement the D&D module
  • Promote and adopt the Risk Enabler
  • Act as single point of contact for project teams
  • Lead strategic topics and decisions
  • Partner with Design Quality Partners and stakeholders
  • Ensure efficient documentation and milestone deliverables
  • Incorporate lessons learned into development requirements
  • Ensure project plans include D&D module deliverables
  • Support internal and external audits
  • Facilitate effective milestone reviews
  • Promote constructive discussions in project meetings
  • Drive risk-based decision making
  • Prepare and ensure effective issue resolution
  • Develop and enhance playbooks and feedback loops
  • Optimize and accelerate Pre-Market Quality contributions
  • Embed and improve knowledge management
  • Enhance change management and information sharing
  • Foster a culture of innovation and continuous improvement
  • Act as a role model and coach colleagues
  • Drive effective decision-making and complexity reduction
  • Promote pragmatic solutions and outcome-focused thinking
  • Travel internationally as required

Berufserfahrung

  • 8 Jahre

Ausbildung

  • Bachelor-AbschlussODER
  • Master-Abschluss

Sprachen

  • Englischfließend
  • DeutschGrundkenntnisse

Tools & Technologien

  • ISO 13485
  • ISO 14971
  • GDP
  • GMP

Benefits

Lockere Unternehmenskultur

  • Diverse and inclusive workplace
  • Personal expression encouraged
  • Open dialogue encouraged
  • Genuine connections fostered

Mentoring & Coaching

  • Personal and professional thriving
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Roche Diagnostics Int. AG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.

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