Associate Director, GDP Operational Quality Specialist

1 day ago


Boston, Massachusetts, United States Vertex Pharmaceuticals Full time
Job Summary

The Associate Director, GDP Operational Quality role is responsible for ensuring that medicines are distributed in the US in compliance with GDP and GMP requirements. This position will work with the GDP Operational QA Management team to maintain the quality of products and ensure compliance with regulatory requirements.

Key Responsibilities
  • Manage the day-to-day quality oversight of the Third Party Logistics provider
  • Provide support for key stakeholders within Vertex
  • Review and maintain Quality Agreements
  • Analyze and resolve compliance and customer issues
  • Escalate issues as necessary
  • Remain up-to-date on GDP and logistics developments and emerging regulations
  • Accountable for New Product Launch activities within the US
  • Collaborate with internal stakeholders to maintain the Quality Management System
  • Ensure distribution licenses accurately reflect the current organization
  • Support recalls, mock recalls, and on-market activities
Requirements
  • Bachelor's degree in a scientific or allied health field and relevant GDP & GMP work experience
  • 5+ years' experience serving in a Quality role
  • Clear understanding of GDP and GMP requirements
  • Influencing skills in areas with no direct reporting authority
  • Strong interpersonal and communication skills
  • Auditing skills, with appropriate qualifications in auditing an advantage
Flexibility

This Hybrid-Eligible role offers the flexibility to work remotely up to two days per week or work five days per week on-site with ad hoc flexibility.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation. We are committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.



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