Job Description

The Quality 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. The ideal candidate will have experience/knowledge in a GDP (Industry) environment, Distribution, Supply Chain and Logistics. This Position Reports to: Senior Quality Manager, GDP Operational Quality

  Key Responsibilities:

• Maintain QMS within the Vertex Pharmaceuticals Incorporated.
• Ensure distribution licences (where required) accurately reflect the current organisation, vary licence where necessary
• Support recalls, mock recalls and any other on-market activity.
• Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.
• Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches.
• Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Distribution licences (or equivalent) application, audits, and Quality Agreements.
• Planning/ Preparation/supporting/hosting for Regulatory inspections
• Providing front and backroom inspection support
• Post inspection follow-up with responses and CAPAs (Continuous improvements)
• Manage/Approve/Assess event investigations “deviations” (including Fast Track deviations)
• Manage CAPAs and Effectiveness Checks
• Perform other duties as per GDP guidelines and Vertex policies and procedures
• Create/review and approve Standard operating Procedures and other Quality Documents

Key Accountabilities:

• 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
• Accountable for New Product Launch activities within the US providing distribution requirements and expectations.
• Working collaboratively with key internal stakeholders
• Support Clinical QA Distribution

Skills:

• Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.
• Influencing skills in areas with no direct reporting authority.
• Strong interpersonal and communication skills.
• Auditing skills, appropriate qualifications in auditing an advantage.
• Fluency in English is required
• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)

Requirements

Qualifications:

• Master’s degree and 3-5 years of relevant work experience, or
• Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 5+ years of relevant work experience, or relevant comparable background.
• GDP experience.
• Auditing experience

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