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Job Details
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Purpose: The NPI Manager drives successful new product launches by orchestrating tech transfer activities and providing comprehensive oversight across complex, multi-component product launches and regulatory processes. He/she oversees and governs the entire NPI process for each new product, providing strict oversight of project status, regulatory and quality compliance, and financial performance. He/she collaborates with global teams and members from senior leadership to develop and execute strategies for commercial supply of new products.
The NPI manager actively reduces standard product costs by identification and implementation of continuous improvement initiatives.
Major Responsibilities
NPI
- Set up governance and team structure for each new NPI program, ensuring that clear Roles and Responsibilities are assigned cross-functionally.
- Direct and manage the NPI program, ensuring adherence to timelines and deliverables.
- Lead alignment of cross-functional teams and program activities.
- Monitor phase gates, milestone transitions, and batch shipments to ensure progress and timely completion of deliverables.
- Support regulatory submission and approval processes, including BLA and PAS submissions.
- Oversee qualification, validation, and operational readiness activities, ensuring all regulatory and compliance requirements are met.
- Drive the release of clinical and commercial batches, ensuring thorough documentation and cross-functional collaboration.
- Proactively identify, mitigate, and resolve risks, dependencies, and bottlenecks across program streams.
- Drive change management and adoption of new products, processes, or systems among all stakeholders.
- Maintain program financial finesse including budgeting, cost tracking, variance analysis, and overall value delivery aligned with business objectives.
- Review program status, progress, risks, and issues to global stakeholders and site leadership team.
- Lead tech transfers out of site.
Project Management
- Identify and manage continuous improvement projects associated with product lifecycle or product costs (non-process derived improvements).
- Bachelor’s Degree or higher in a Science, Engineering or Quality discipline.
- 7+ years’ experience in manufacturing, supply chain management, engineering, and/or drug development.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
- Excellent organizational and project management skills.
- Strategic leadership and senior stakeholder influence.
- Strong ability to identify, manage and resolve risks proactively and independently.
- Ability to work in a highly dynamic and changing environment.
- Familiarity with product lifecycle demands and site’s capabilities.
- Familiarity with documentation and regulatory requirements for product launches.
- Experience with change management practices and tools.
- Financial acumen with experience in budgeting and cost management.
- Advanced analytical and decisive problem-solving.
- Proficient in leading and coordinating international cross-functional teams.
- Strong ability in influencing peers in other organizations and senior management.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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