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