Global Serialization Associate Director

Job Description

General Summary:

The Serialization Associate Director contributes to the design, implementation and maintenance of global serialization / track and trace at Vertex. The Serialization Associate Director acts as a primary serialization contact on new product launch working teams, creates and maintains serialization SOPs and troubleshoots serialization related operational issues to ensure no disruption to commercial supply. The Serialization Associate Director independently manages multiple projects or phase(s) of a larger project related to serialization and master data management and builds relationships with internal and external stakeholders to ensure seamless product launch and uninterrupted commercial supply.

Key Duties and Responsibilities:

• Oversee alert management processes
• Maintain quality system governance such as SOPs / business process updates
• Lead new product / SKU expansion launches
• Lead master data management efforts
• Lead change control management / documentation management
• Lead exceptions / issue management and reporting
• Develop, deliver and maintain serialization training
• Manage operational projects and implementation of initiatives, improvements, etc.
• Contribute to serialization process continuous improvement
• Conduct special projects as directed by management

Knowledge and Skills:

• In-depth experience managing a range of complex projects in the pharmaceutical industry.
• Strong ability to multi-task and prioritize work in a fast paced environment.
• Excellent communication skills and capable of interacting with all levels within a geographically dispersed organization
• In-depth analytical and organization skills and strong detail orientation.
• Able to build mutual trust and encourage respect and cooperation among team members.
• Exercises sound judgment troubleshooting problems and escalating issues appropriately; takes a new perspective on existing solutions and works effectively across departments and levels, building alignment around proposed solutions
• In-depth knowledge of applicable regulations (e.g., GMP. GCP, Part 11).
• Strong knowledge of Microsoft Excel, Project, PowerPoint and Visio are required
• PMP certification preferred

Education and Experience:

• Bachelor's degree in relevant discipline
• Typically requires 8 years or the equivalent combination of education and experience
• Experience working with software systems validation, FDA cGxP and 21 CFR Part 11 regulations

Pay Range:

Disclosure Statement:

Flex Designation:

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