NPI Program Manager
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Campoverde, Lazio
- Operations
- Internal Manufacturing
- Full-time
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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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
AbbVie is looking for an NPI Program Manager with following responsibilities in Campoverde site.
Job Core Responsibilities GMP
- Leading cross-functional teams for New Product Introduction and major changes programs to support the Abbvie/CMO pipeline and products launch strategy in a timely, consistent and effective way.
- Leading cross-functional teams for strategic site projects and initiatives
- Developing and applying an integrated and efficient system to support feasibility studies by providing planning capabilities, technical, GMPs, EHS and financial evaluation and balancing products life cycle and volumes with new products introduction.
- Ensuring compliance with GMPs, Abbvie Quality Policies, Regulatory rules and Regulation all through the Program.
- Ensuring communication and knowledge sharing all through and after the programs with particular reference to programs outputs.
Job Responsibilities EHS
- Demonstrates accountability and responsibility for EHS and Energy performance and compliance through active participation and support of EHS and Energy Program. He/She is a “lavoratore” in accordance to D.Lgs. 81/08
Description of Responsibilities GMP
- The responsibility includes:
- Supplying leadership in leading the project team taking advantage of the previous working experiences.
- Being responsible for achievement of program milestones and financial targets.
- Identify learning needs and potential risks to ensure the project is realized in a timely and cost-effective manner.
- The responsibility includes:
- Support cross-functional teams to define and execute the strategic site projects and initiatives for the growth and sustainability of the site.
- Being responsible for achievement of strategic projects according to the timelines
- The responsibility includes:
- Ensuring the Project activities are conducted considering all site contingencies such as the consolidated products life cycles and volumes.
- Ensuring a risk-based approach is used through the whole execution of the program plan both in QA, Financial and EHS fields.
- Using project management tools and metrics integrated with the site business process to establish a routine environment and a life cycle approach to all manufacturing operations.
- The responsibility includes:
- Being a guarantor that the project is performed in all its aspects in compliance with GMPs, Abbvie Quality Policies and Regulatory Agencies regulations and State Laws.
- The responsibility includes:
- Constantly communicating with the Global and Local references in order to keep up to date about the Program status or about possible issues.
- Facilitating the communication within the project team functions by sharing information and promoting knowledge exchange through periodic meetings, meeting minutes and summaries and by using project management tools.
- Contributing to develop and apply an NPI Value Stream Methodology aligned with the Abbvie network in order to identify opportunities of improvement in the site.
Description of responsibilities EHS
- The responsibility includes:
- Demonstrating accountability and responsibility for EHS and Energy performance and compliance through all programs with active participation and support of AbbVie’s EHS program
- Guaranteeing all EHS aspects are fully considered and properly managed in the programs for new products introduction and major product changes
- Degree in Chemistry, Pharmaceutical Chemistry or Engineering
- At least 5 years of experience in manufacturing, engineering, tech ops, quality area
- Experience in Chemical and Pharma NPI projects as team member
- Knowing of quality systems (i.e. Soltraq, OneVault) and experience in the change management process
- Fluent English language
- Previous experience as Project Leader for Manufacturing Area/NPI projects is considered a plus
- Previous experience in several roles within the organization (such as manufacturing, QA, compliance/regulatory, Tech Ops, engineering) is considered as a plus.
This announcement is aimed at both sexes, pursuant to laws 903/77 and 125/91, and to people of all ages and all nationalities, pursuant to legislative decrees 215/03 and 216/03. The personal data contained in CVs will be processed and stored exclusively for selection purposes, in compliance with Legislative Decree 196/2003 and subsequent amendments and Regulation (EU) 2016/679.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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