Vertex · 23 hours ago
Distribution Quality, Manager
Boston, MA
Full-time
Onsite
Mid, Senior LevelVertex is a global biotechnology company that invests in scientific innovation. They are seeking a Distribution Quality Manager responsible for ensuring compliance with quality and GDP regulatory standards in the distribution of medicinal products. The role involves collaboration with various stakeholders to resolve quality issues and support quality processes related to the distribution of commercial finished goods and raw materials.
Computer Software
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
Qualification
Required
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
Benefits
Medical, dental and vision benefits
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)
Company
Vertex
Vendor intelligence that combs through your supplier, manufacturer, logistics data to detect where you're leaving money on the table.
Founded in 2024
2-10 employees
H1B Sponsorship
Vertex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (18)
2023 (7)
2022 (13)
2021 (5)
2020 (7)
Funding
Current Stage
Early StageCompany data provided by crunchbase