Quality Assurance Manager, Distribution (Contract) 28814

The Manager 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 Manager 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

Key Duties and Responsibilities:

• 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
• 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
• Maintain QMS within the Vertex Pharmaceuticals Incorporated.
• Ensure distribution licenses (where required) accurately reflect the current organization vary license 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 licenses (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)

Qualifications/Knowledge/Skills:

• Bachelors degree in a scientific or allied health field (or equivalent degree)
• GDP work experience or relevant comparable background.
• Ability to work under moderate supervision
• Ability to work and coordinate cross-functionally
• Experience with and ability to use Microsoft Office and associated tools (Word Excel PowerPoint)
• Demonstrated experience with handling compliance issues resulting from deviations or product defects
• Proactive approach and strong critical thinking skills
• Must be able to work in a team environment within own team and inter-departmental teams
• Excellent communication and interactive skills
• Technical Writing
• Good organizational and time management skills and able to demonstrate flexibility and adaptability.
• Able to prioritize workload decisive thinker able to work within agreed timescales.
• A high Level of attention to detail

$70-$73/hr

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other job-related factors permitted by addition this role will be eligible for overtime pay in accordance with federal and state requirements

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