Global Serialization Associate Director

Vertex Inc. • Boston, MA

22h • Hybrid

About The Position

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.

Requirements

• 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
• 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

Nice To Haves

• PMP certification preferred

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

Benefits

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director