Job Title: Project Manager Stability Optimization
Company:
AbbVie
Description:
We are currently hiring a Project Manager Stability Optimization to be based in Ireland or connected to one of our sites in Europe. This person will have the opportunity to make a significant impact on optimizing AbbVie's stability and QC programs, working closely with the Regional Strategic Lead.
Key Responsibilities:
* Manage a project to optimize AbbVie Operation's stability program with the following objectives and deliverables:
* Understand the current state by creating a holistic picture of ongoing stability studies, assessing compliance with ICH Q1D, and analyzing the cost structure.
* Design the future state by reducing test points on commercial annual stability studies leveraging ICH Q1D, and implementing a matrix approach for presentations per product.
* Closely collaborate with cross-functional teams to ensure the optimum approach is identified, technical memos are drafted, change plans are completed, and regulatory submissions are prepared and submitted.
* Apply project management principles and tools to develop a robust project plan, monitor progress, manage stakeholders, and provide regular updates to QA executive management.
Requirements:
* 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, and first-hand experience in Regulatory Affairs.
* 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.
Additional Information:
AbbVie is an equal opportunity employer committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. Salary may vary depending on the location of the role.