Manager, Distribution Quality

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 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
• Finish Goods Release at 3PL
• Remain up to date on 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.
• Work collaboratively with key internal stakeholders
• Support Clinical QA Distribution
• Maintain QMS within Vertex Pharmaceuticals Incorporated.
• Ensure distribution licences (where required) accurately reflect the current organisation; vary licences 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 back-room inspection support
• Post-inspection follow-up with responses and CAPAs (continuous improvement)

Qualifications/Knowledge/Skills:

• Bachelor’s degree in a scientific or allied health field
• Strong knowledge of international GDP regulations; good knowledge of GMP regulations.
• Good understanding of ICH Q9 and the ability to apply risk-based approaches to lead and develop efficient solutions that balance compliance and business requirements.
• Ability to proactively identify risk and develop mitigation strategies.
• Ability to collaborate cross-functionally with good communication skills and the ability to influence others by leveraging active listening and delivering articulate and convincing ideas.
• Ability to align and adjust activities within one’s scope of ownership to positively embrace change and support business growth and process improvements.
• Demonstrates ability to effectively communicate to one’s team, local, international, and global audiences, with integrity
• Ability to leverage critical and strategic thinking to determine and mitigate complex challenges and impact.
• Ability to apply business acumen and leadership skills across all relevant aspects of one’s role; skilled at time and resource management.

Pay Range

$65-$75/hr

Requisition Disclaimer

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 law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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