Director, GDP Operational Quality; Hybrid

Director, GDP Operational Quality (Hybrid)

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Job Description

The Director, GDP Operational Quality is responsible to partner with Trade Operations to support the distribution of Vertex’s commercial product portfolio. The role oversees team activities, develops personnel, and ensures timely completion and quality of deliverables/goals within their remit. The role supports GDP quality operations for all distribution activities within the US; key stakeholders include Trade Operations, Vendor Quality Management & Quality Compliance.

Key Duties And 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 organization operates within the Vertex GDP Quality Management System, ensuring 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), driving activities set out in the SS&D Roadmap.
• Manage quality oversight and management of Vertex strategic US third‑party logistics providers (creating and maintaining Quality Agreements, developing KPIs, establishing meetings, and participating in governance forums).
• Support inspection preparation and management for authority inspections and manufacturing locations.
• Participate in the GDP Management Review process—review and assess risk inputs such as metrics, regulatory intelligence, and identified gaps; recommend mitigation approaches.
• Participate in New Product Launch activities to ensure Quality related actions are planned and completed.
• Act as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classify, and strategize GDP/GMP actions.
• Develop and refine tools to ensure efficiency in execution of Distribution Quality Processes.

Qualifications/Requirements/Skills

• GDP & GMP work experience or relevant comparable background.
• Expert knowledge of International GDP regulations; broad knowledge of GMP and GVP regulations.
• Experience applying risk‑based quality principles in a pharmaceutical environment.
• Demonstrated capability to lead a team through organizational change in a dynamic environment.
• Proven leadership in designing and implementing quality strategies that support commercial and supply‑chain partners.
• Strong collaboration and communication skills across all organizational levels; ability to persuade, negotiate, and achieve consensus.
• Highly skilled at driving continuous process improvements and managing change.
• Excellent time, resource, and project management; prioritization and organizational skills.
• Advanced technical writing and communication skills for local, regional, and global audiences.
• Experience in managing performance and career development for teams.
• Strong analytical and problem‑solving abilities; data‑analysis skills.
• Demonstrates Vertex behaviours.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).

Education And Experience

• Bachelor’s degree in a scientific or allied health field.
• Typically requires 10 years of relevant work experience or equivalent education and experience.

Role

Hybrid or On‑Site Eligible. Choose to work remote up to two days per week or on‑site five days per week with ad‑hoc flexibility.

Pay Range

$182,400 - $273,500

Disclosure Statement

The range provided is based on a reasonable estimate for the base salary at the time of posting. This role is eligible for an annual bonus and equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary depends on skills, experience, and other factors permitted by law.

Benefits

Vertex offers inclusive, market‑leading benefits: medical, dental, vision, paid time off, company shutdowns, educational…