Senior Compliance Specialist

hace 2 semanas


Buenos Aires, Buenos Aires C.F., Argentina Global66 A tiempo completo
Job Description

The Position: The Quality and Compliance Lead (QCL) is the Quality and Compliance expert who drives GcP / GvP topics across the organization to proactively manage Quality and Compliance throughout the drug/device lifecycle.

Key Responsibilities:

  • Leads the organization to identify and mitigate risks throughout the drug/device lifecycle to ensure patient safety and data integrity.
  • Initiates and manages any quality and compliance topics to continuously improve our Quality Management System.
  • Provides quality and compliance consultancy to enable fast and efficient research and development, market authorizations, and maintain licenses for our portfolio of products within the region.
  • Contributes local insights into the Global Quality Medicine Strategy and executes the strategy at a regional level.

Requirements:

  1. Master's degree preferred or Bachelor's in a life science or other scientific discipline with several years of work experience.
  2. At least 5 years of experience in Quality Management in the Pharma Industry.
  3. GvP & GcP Knowledge and expertise.
  4. Regulatory audits management.
  5. Communication skills: able to communicate effectively, clearly and concisely with all individuals across BI regardless of their position or relationship.
  6. Influencing & negotiating skills: able to clearly articulate options and their potential implications and reach an agreement with all individuals across BI regardless of their position or relationship.
  7. Leadership skills: able to lead Quality and Compliance topics and teams (including matrix or project teams) effectively to deliver the responsibilities effectively.
  8. Level of English: Advanced.
  9. Presentation skills: able to design and deliver effective presentations to achieve the required outcomes (desirable).
  10. Risk management: able to identify and manage risks effectively (desirable).
  11. Ability to travel regionally and internationally as needed (desirable).


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