Job Information
AbbVie Project Manager Stability Optimization in Dublin, Ireland
Company Description
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 X (https://twitter.com/abbvieireland) , Facebook, Instagram (https://www.instagram.com/abbvieireland/) , YouTube and LinkedIn.
Job Description
We are currently hiring a Project Manager Stability Optimization to join an exciting project for a 1 years Fixed Term Contract. This person will have the opportunity to have a significant impact on optimizing AbbVie’s stability program, working closely with the Regional Systems Lead. This person can be based in Ireland or Chicago. The role reports to the Regional QA Systems Lead.
Manage a project to optimize AbbVie Operation’s stability program with the following objectives and deliverables:
Understand the current state
Create a holistic picture of the currently ongoing stability studies, including number of studies, timepoints per study, type of study, presentation matrix
Assess the compliance of the currently ongoing stability program with ICH Q1D
Assess and analyze the cost structure of the existing stability program
Design the future state with the intention to
Reduce the number of test points on commercial annual stability studies leveraging ICH Q1D
Reduce the number of presentations per product on stability through matrix approach.
To realize this, closely collaborate with a cross-functional team of experts to ensure
The optimum approach for product matrix and timepoints has been identified
Technical memos have been drafted to support the proposed approach
Change plans per product/studies have been completed to enable the identified efficiencies
Regulatory submissions (AR, CBE-0, CBE-30, PAS/Type IA, Type IAin, Type IB, Type II) have been prepared and submitted by RA CMC team
The reduced testing based on primary markets and risk assessment has been implemented
Apply project management principles and tools to
Develop a robust project plan to meet the objectives and deliverables above
Monitor and track project progress against the project plan; adjust the plan as needed
Manage key stakeholders of the program
Provide regular updates to QA executive management
Qualifications
BS/BA degree in Science/Engineering/Business Management, or other related field of study
5 years of experience in the pharmaceutical industry, solid knowledge and understanding of cGxPs; first-hand experience in Regulatory Affairs preferred
In-depth knowledge of global regulatory requirements for stability studies
Project Management experience, PMP certification preferred
Excellent verbal and written communication skills, effective facilitation and collaboration with a cross-functional team
Excellent negotiation and influencing skills
High level of competence, confidence, and credibility for interaction with senior management.
Demonstrate high level of independence, decision making, anticipate program scope and deliverable changes, and effectively communicate issues with management
Please note that salary and grade may vary depending on the country location of the role.
Additional Information
AbbVie 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.