Distribution Quality, Manager

Vertex Inc. • Boston, MA

1d

About The Position

Responsible for the principles and application of quality and GDP regulatory compliance supporting the global processes for distribution of Vertex materials, intermediates, and finished medicinal products (commercial) across its global distribution network. Stakeholders include GMP QA, Market Quality, Global Logistics, Vendor Management and AIM. This position reports directly to: Associate Director/Director, Distribution Quality

Requirements

• Bachelor’s degree in a scientific or allied health field
• Strong knowledge of International GDP regulations; Good knowledge of GMP and GVP 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

Responsibilities

• Distribution Quality subject matter expert providing technical and strategic direction to functional areas including Global Logistics on network and transport strategy projects, change controls, deviations, qualification and risk assessments.
• Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions and provide technical guidance specifically to functional areas including Global Logistics.
• Support the Quality Processes/Process Ownership for the distribution of product agnostic Commercial Finished Goods raw materials and intermediates. These processes will cover controls and oversight at Vertex office operations, GMP storage providers and transport providers.
• Preparation and maintenance of Quality Agreements
• Review of deviations, CAPA and changes identified.
• Support the lifecycle management of distribution partners , vendor related plans, and ongoing gaps or risks for programs engaging with cross functional teams.
• Attend Quarterly Business Reviews
• Maintaining KPIs
• Analyze, resolve, or assist in solving compliance and customer issues.
• Escalation of issues
• Support the activities for Shipping qualification for Global Logistics for the new products: Oversight of shipping qualification within Global Logistics Quality-related actions are planned into projects and completed in line with the commitments and that controls and oversight from Vertex are implemented
• Provide front and backroom inspection support and post-inspection follow-up with responses and CAPAs.
• Support DMQ in gathering relevant documentation for disposition on temperature excursions.
• Support the GDP Management Review process (metric review, regulatory intelligence, identification of risks and gaps)
• Manage/approve/assess event investigations (deviations)
• Manage CAPAs and effectiveness checks.
• Support recalls, mock recalls, and any other in-market activity.
• Serve as QA assessor on Change Controls: resolve gaps and identify strategy for GDP/GMP actions.

Benefits

• This role is eligible for an annual bonus and annual equity awards.
• Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
• At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
• From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager