Quality Assurance Senior Specialist, Distribution (Contract) 28815

Job description

Job Description The Senior Specialist role will work with the GDP Operational QA Management team to ensure that medicines are distributed in the USA in compliance with GDP and GMP requirements. The Quality Senior Specialist will manage the day-to-day Quality oversight of the Third Party Logistics providers and provide support for key stakeholders within Vertex. This position reports directly to: Senior Manager, Distribution Quality, US Qualifications/Knowledge/Skills: - Support the oversight of Distribution Partners within the USA, including: - Preparation and maintenance of Quality Agreements - Review of deviations, CAPA and changes - Maintaining KPIs - Analyze, resolve, or assist in solving compliance and customer issues. - Escalation of issues - Finish Goods Release at 3PL - Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMS - Working collaboratively with key internal stakeholders - Support Clinical QA Distribution - Maintain QMS within the Vertex Pharmaceuticals Incorporated. - Support recalls, mock recalls and any other on-market activity. - Serve as QA assessor/approver on Change Controls: resolve gaps, approve cha...