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Skills Alliance

Vice President of Quality

Skills Alliance, WorkFromHome

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I am partnered with an exciting, growing radiopharmaceutical organisation looking to hire the most senior member of their QA function.

The individual will develop and lead the QA function for all development activities to ensure regulatory compliance, product safety, data integrity and patient focus.

The role:

  • Design, implement and maintain the Quality Management System to ensure compliance with relevant GMP, GDP, GLP, GCP and GPvP guidelines.
  • Implement and manage a vendor management program for qualification and oversight of GxP vendors.
  • Represent the QA function internally and act as key point of contact for all GxP compliance issues, queries and guidance.
  • Implement and manage a system of training to ensure that all staff are trained to conduct GxP responsibilities in alignment with their job description.
  • Host regulatory inspections.

The individual:

  • Significant experience in development, manufacturing and quality aspects of radiopharmaceuticals.
  • Background in engaging with regulatory bodies such as FDA, EMA, and various national European agencies through activities including facility inspections, scientific consultations, and addressing regulatory inquiries.
  • Skilled in developing, establishing, and managing Quality Management System frameworks.
  • Proven ability to guide and direct quality assurance teams toward optimal organizational outcomes.

Seniority level

  • Seniority level

    Director

Employment type

  • Employment type

    Full-time

Job function

  • Job function

    Quality Assurance

  • Industries

    Pharmaceutical Manufacturing and Biotechnology Research

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