Vertex · 3 months ago
Director, GDP Operational Quality (Hybrid)
Boston, MA
Full-time
Hybrid
Director/Executive
$182K/yr - $274K/yr
10+ years expVertex is a global biotechnology company that invests in scientific innovation. The Director, GDP Operational Quality is responsible for overseeing the quality operations related to the distribution of Vertex’s commercial product portfolio, ensuring compliance with GDP quality standards and leading continuous improvement initiatives.
Computer Software
Responsibilities
Primary quality partner for Vertex US Trade Operations organization, providing quality input and perspective to US Trade Ops continuous improvement initiatives and projects
Accountable for ensuring US Trade Ops organisation are operating within the Vertex GDP Quality Management System, accountable to ensure deviations are investigated, recorded in the QMS and CAPAs are identified
Establish robust Quality Processes/Process Ownership for the distribution of Vertex Commercial Finished Goods within the US
Responsible for local release activities required to support distribution of Vertex Commercial products
Support Trade Operations with Risk Management activities
Support the Shipping, Storage & Distribution (SS&D) Process Owners Network (PON). Build, maintain and drive and manage PON activities set out in the SS&D Roadmap
Responsible for the Quality oversight and management of Vertex strategic US third party logistics providers : creating and maintaining Quality Agreements, developing KPIs, establishing Quality meetings and participating in governance forums
Support inspection preparation and management, prior to, during and following any Authority inspection; Support manufacturing locations as required
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 New Product Launch activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g., QMS build out, audits, and Quality Agreements
Act as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions
Develop, utilize and continue to mature tools to ensure efficiency in execution of Distribution Quality Processes
Qualification
Required
GDP & GMP work experience, or relevant comparable background
Expert knowledge of International GDP regulations; broad knowledge of GMP and GVP regulations
Knowledge and demonstrated experience in application of risk-based quality principles in a pharmaceutical environment
Demonstrated capability to lead a team through organisational change and a dynamic/ evolving business model
Proven leadership ability to design/evolve and implement quality strategies to support their commercial and supply chain partners in both a clinical and commercial setting
Strong ability to collaborate cross functionally across all levels of the organization with strong communication skills and the ability to persuade others to adopt a new point of view, achieve consensus and negotiate effectively
Highly skilled at managing change, and driving Continuous Process improvements
Highly skilled at time and resource management, prioritization of own work and departmental initiatives, and planning/organization skills
Highly skilled in technical writing
Demonstrates advanced ability to effectively communicate to local, international and global audiences
Significant experience in managing/leading others to include performance management and career development
Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions
Demonstrates the Vertex behaviours
Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)
Bachelors degree in a scientific or allied health field
Typically requires 10 years of relevant work experience, or the equivalent combination of education and experience
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.
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