Project Manager QC & Stability

Job title:

Project Manager QC & Stability

Company

AbbVie

Job description

Company DescriptionAbbVie’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 . Follow @abbvie on , , , and .Job DescriptionWe 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 have a significant impact on optimizing AbbVie’s stability and QC programs, working closely with the Regional Strategic 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 location of the role.Additional InformationAbbVie 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.US & Puerto Rico only – to learn more, visitUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Expected salary

Location

Dublin

Job date

Fri, 15 Nov 2024 23:56:21 GMT

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