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Regional Compliance and Quality Manager

3 semanas atrás

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$1.000.000 - R$1.250.000
Job Description

As a seasoned Regulatory and Quality professional, you will have the opportunity to lead local regulatory and quality teams to deliver on local responsibilities outlined in regulations, policies, and internal standards. You will be responsible for overseeing the implementation and execution of the Corporate Quality System at designated affiliates within Alexion.

Key aspects of the role include:

  • Leading local regulatory and quality teams to deliver on local responsibilities
  • Overseeing country affiliate input to regulatory strategies for portfolio products in development and commercial quality aspects
  • Collaborating with global regulatory leads to advise on clinical trial strategy and national scientific advice if relevant
  • Partnering with Commercial, Medical Affairs, Business Operations, and Management to define regulatory and quality priorities based on business opportunities and affiliate objectives
  • Accountable for all interactions with local Health authorities, including health authority meetings, inspections, and other regulatory compliance aspects
Required Skills and Qualifications

To succeed in this role, you will need:

  • A bachelor's degree in life sciences, preferably with an advanced degree (PhD or PharmD)
  • 10 years of hands-on experience in regulatory and/or quality assurance/compliance management in the pharmaceutical/biotech industry
  • Thorough knowledge of applicable local and global regulatory requirements for GXP compliance
  • Extensive knowledge in a broad range of pharmaceutical regulatory activities and quality systems
  • Strong management and leadership ability
  • Exceptional communication and interpersonal skills
  • Ability to work globally in a matrix environment
  • Ability to influence senior management, peers, and colleagues
What You Will Achieve

In this role, you will have the opportunity to drive regulatory and quality excellence, ensuring full compliance with local regulations and corporate policies. You will also be responsible for leading local regulatory and quality teams, overseeing the implementation of the Corporate Quality System, and collaborating with global regulatory leads.

You will have a significant impact on the company's success, influencing senior management, peers, and colleagues, and driving innovation and improvement across the organization.

This is a unique opportunity to grow your career as a Regulatory and Quality leader, working in a fast-paced and dynamic environment.