Job Description

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/COIProcess OwnershipThe chain of identify/chain of custody process owner is accountable for theend-to-endprocess for cell and gene therapy programs.

• Ensure clearly documented, compliant end to end processfor traceability ofcommercial or to be launchedcell and geneprograms

• Develop andmaintainCOC/COI continuous improvement roadmaps for relevant systems, ensuring alignment with organizational goals and industry best practices.

• Define and managerequirements for COC/COI-related system changes , ensuring updates are compliant with regulations and effectively implemented.

• Leadprocess mapping exercises to align systems with organizational needs.

• Partner with DTE to defineuser requirementsfor current and future systems

• Managetraining andchangeprocess with internal stakeholders, CMOs and ATCs

Compliance and Partner Management

• Conduct regularbusiness reviews with manufacturing partners to assess COC/COI compliance, address challenges, andidentifyopportunities for improvement.

• Advocate forCOC/COI standards across commercial and cross-functional teams, promoting awareness and adherence to compliance requirements.

• Partner with quality teams to managedeviationsimpactingCMOs (Contract Manufacturing Organizations) and ensure proper tracking, documentation, and resolution.

Leadership and Reporting

• Prepare and presentleadership reports on COC/COI compliance, including progress updates, key metrics, and alignment with organizationalobjectives.

• Leadcross-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 throughsystem enablement , including managing support tickets and resolving issues raised by external partners.

• Coordinatechange management activities , such as change control oversight, communication of system/process changes, training, and onboarding of CMO users.

• Supportlabeling and other quality-related requests to ensure audit readiness and compliance.

Training and Development

• Providetraining to end users on COC/COI systems and processes.

Knowledge and Skills:

Technical and Industry Knowledge:

• Hands-on experience withsupply chain planning systems

• Experienceoperatingwithin aGxPenvironment

• Conceptual understanding ofmaterial flows in a virtual manufacturing environment

Soft Skills:

• Strongorganizational skills and ability to prioritize work in a dynamic environment.

• Ability to work bothindependently and collaboratively in a team setting.

• Strongwritten and verbal communication skills to explain complex information and build consensus.

Project Management:

• Ability toassistin theexecution of projects with diverse scope and complexity.

• Experience inchange management activities , including training, communication, and onboarding.

Education and Experience:

• Bachelor’s degree inrelevantdiscipline.

• Typically requires5 to 7 years of work experience in supply chain planning or an equivalent combination of education and experience.

Pay Range:

$154,500 - $231,700

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. 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. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

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.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid work remotely up to two days per week; or select
2. On-Site work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com