Associate Director, Supply Chain, COC/COI

Vertex Pharmaceuticals • Boston, MA

4d • Hybrid

About The Position

General Summary: The Supply Chain Associate Director has broad influence within established global supply networks and will foster interdisciplinary understanding and integrate activities both within and outside the Commercial Manufacturing and Supply Chain organization. The Associate Director will manage all business aspects of the Certificate of Compliance (COC) and Chain of Identity (COI) as an individual contributor. The Associate Director sets the standards for work within their discipline/area and has responsibility for the development of related goals, resource plans and budgets.
Key Duties and Responsibilities: COC/COI Process Ownership The chain of identify/chain of custody process owner is accountable for the end-to-end process for cell and gene therapy pro grams. Ensure clearly documented, compliant end to end process for traceability of commercial or to be launched cell and gene programs Develop and maintain COC/COI continuous improvement roadmaps for relevant systems, ensuring alignment with organizational goals and industry best practices. Define and manage requirements for COC/COI-related system changes , ensuring updates are compliant with regulations and effectively implemented. Lead process mapping exercises to align systems with organizational needs. Partner with DTE to define user requirements for current and future systems Manage training and change process with internal stakeholders, CMOs and ATCs Compliance and Partner Management Conduct regular business reviews with manufacturing partners to assess COC/COI compliance, address challenges, and identify opportunities for improvement. Advocate for COC/COI standards across commercial and cross-functional teams, promoting awareness and adherence to compliance requirements. Partner with quality teams to manage deviations impacting CMOs (Contract Manufacturing Organizations) and ensure proper tracking, documentation, and resolution. Leadership and Reporting Prepare and present leadership reports on COC/COI compliance, including progress updates, key metrics, and alignment with organizational objectives. Lead cross-functional working groups to ensure alignment and readiness for system and process changes. System and Partner Support Act as Process Owner for systems supporting external manufacturing, managing customer requests, and collaborating with business and technical teams on enhancements and issue resolution. Support CMOs through system enablement , including managing support tickets and resolving issues raised by external partners. Coordinate change management activities , such as change control oversight, communication of system/process changes, training, and onboarding of CMO users. Support labeling and other quality-related requests to ensure audit readiness and compliance. Training and Development Provide training to end users on COC/COI systems and processes.

Requirements

• Hands-on experience with supply chain planning systems
• Experience operating within a GxP environment
• Conceptual understanding of material flows in a virtual manufacturing environment
• Strong organizational skills and ability to prioritize work in a dynamic environment.
• Ability to work both independently and collaboratively in a team setting.
• Strong written and verbal communication skills to explain complex information and build consensus.
• Ability to assist in the execution of projects with diverse scope and complexity.
• Experience in change management activities , including training, communication, and onboarding.
• Bachelor’s degree in relevant discipline.
• Typically requires 5 to 7 years of work experience in supply chain planning or an equivalent combination of education and experience.

Responsibilities

• Ensure clearly documented, compliant end to end process for traceability of commercial or to be launched cell and gene programs
• Develop and maintain COC/COI continuous improvement roadmaps for relevant systems, ensuring alignment with organizational goals and industry best practices.
• Define and manage requirements for COC/COI-related system changes , ensuring updates are compliant with regulations and effectively implemented.
• Lead process mapping exercises to align systems with organizational needs.
• Partner with DTE to define user requirements for current and future systems
• Manage training and change process with internal stakeholders, CMOs and ATCs
• Conduct regular business reviews with manufacturing partners to assess COC/COI compliance, address challenges, and identify opportunities for improvement.
• Advocate for COC/COI standards across commercial and cross-functional teams, promoting awareness and adherence to compliance requirements.
• Partner with quality teams to manage deviations impacting CMOs (Contract Manufacturing Organizations) and ensure proper tracking, documentation, and resolution.
• Prepare and present leadership reports on COC/COI compliance, including progress updates, key metrics, and alignment with organizational objectives.
• Lead cross-functional working groups to ensure alignment and readiness for system and process changes.
• Act as Process Owner for systems supporting external manufacturing, managing customer requests, and collaborating with business and technical teams on enhancements and issue resolution.
• Support CMOs through system enablement , including managing support tickets and resolving issues raised by external partners.
• Coordinate change management activities , such as change control oversight, communication of system/process changes, training, and onboarding of CMO users.
• Support labeling and other quality-related requests to ensure audit readiness and compliance.
• Provide training to end users on COC/COI systems and processes.

Benefits

• 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: Mid Level
• Number of Employees: 1,001-5,000 employees