Associate Director, GDP Operational Quality Specialist
4 weeks ago
The Associate Director, GDP Operational Quality role will work closely with the GDP Operational QA Management team to ensure compliance with GDP and GMP requirements for the distribution of medicines in the US.
This position will manage the day-to-day quality oversight of Third Party Logistics providers and provide support to key stakeholders within Vertex.
Key Responsibilities- Manage the preparation and maintenance of Quality Agreements with Distribution and Logistics partners
- Review deviations, CAPA, and changes to ensure compliance
- Maintain Key Performance Indicators (KPIs) for quality metrics
- 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, providing distribution requirements and expectations
- Collaborate with internal stakeholders to maintain a Quality Management System (QMS)
- Ensure distribution licenses accurately reflect the current organization
- Support recalls, mock recalls, and on-market activities
- Participate in expansion activities to ensure quality-related actions are planned and completed
- Bachelor's degree in a scientific or allied health field and relevant GDP & GMP work experience
- 5+ years of experience in a Quality role
- Clear understanding of GDP and GMP requirements
- Influencing skills with no direct reporting authority
- Strong interpersonal and communication skills
- Auditing skills and qualifications in auditing an advantage
- Fluency in English required
- Proficiency in using Microsoft Office applications required
This Hybrid-Eligible role offers the flexibility to work remotely up to two days per week or on-site with ad hoc flexibility.
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Associate Director, GDP Operational Quality
4 weeks ago
Boston, Massachusetts, United States Vertex Pharmaceuticals Full timeJob Summary:The Associate Director, GDP Operational Quality role will oversee the quality assurance of medicines distributed in the US, ensuring compliance with GDP and GMP requirements.This position will manage the day-to-day quality oversight of the Third Party Logistics provider and provide support for key stakeholders within Vertex.Key...
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