Manager, Distribution Quality (Contract) 839

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 90,000 - 103,000; Full time

Job summary

Vertex Pharmaceuticals LLC in the U.S. state of Massachusetts seeks a Manager to oversee GDP and GMP compliance for distribution activities.

You will manage day-to-day quality oversight of third-party logistics partners and support stakeholders across Vertex in distribution quality. The role reports to the Senior Manager, Distribution Quality, US and requires collaboration with cross-functional teams to ensure compliant product launches and ongoing quality improvement.

Qualifications

• Bachelor’s degree in a scientific or allied health field.
• Strong knowledge of GDP regulations and GMP compliance.
• Experience leading quality oversight of third-party logistics providers.
• Ability to drive risk-based quality decisions.

Responsibilities

• Provide day-to-day quality oversight of 3PLs in the USA.
• Prepare and maintain Quality Agreements; review deviations, CAPA, and changes.
• Maintain KPIs and analyze regulatory and customer-related issues.
• Escalate issues as required and support recalls and incidents.
• Lead change controls and participate in GDP/GMP-related QMS initiatives.
• Support Regulatory inspections and post-inspection CAPAs.

Skills

GDP knowledge

GMP knowledge

ICH Q9

Risk mitigation

Cross-functional collaboration

Regulatory inspections

Education

Bachelor’s degree in a scientific or allied health field

Job description

Job Description

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 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
• 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)

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 development of 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