New Product Introduction (NPI) Manager (Tuas based)
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Job Location:
Monthly Salary:
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
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).
Qualifications :
- Bachelors 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 sites 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.
Additional Information :
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.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
