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Project Manager Stability Optimization

3 months ago

North Chicago, United States AbbVie Full time


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 atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.


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 AbbVies 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 Operations 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

               

              Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

               

            • The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more or less than the posted range. This range may be modified in the future.
          • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance and 401(k) to eligible employees.
        • This job is eligible to participate in our short-term incentive programs.

          Note: No amount of payis a considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law.

          AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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.