at AbbVie in North Chicago, Illinois, United States
Job Description
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 Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
The Program Manager – Clinical Quality Assurance is primarily responsible for leading the management of GCP quality activities in support of studies and
projects across one or more clinical programs to drive proactive quality management, and ensure compliance with corporate policies and functional procedures and applicable global regulations. As the primary GCP quality interface cross-functionally in R&D for the product, this individual will influence and provide oversight of activities that include execution of the Comprehensive Quality Strategy game plan, informal surveillance, assessments as appropriate, design and execution of a “fit for purpose” audit program with the goal of submission-ready quality data, first pass approvals by health authorities for market authorizations, and bringing our compounds to our patients. This is an independent contributor role that will influence across matrix organizations.Responsibilities:
+ Develop and manage project timelines and deliverables for the RDQA Comprehensive Quality Strategy plan, including a lead role in Risk and Issue Management
+ Assess the success and effectiveness of the quality system and assure inspection readiness by designing an audit program of internal and external compliance audits and applicable assessments
+ Interpret, explain and apply applicable current governmental regulations, guidelines, policies and procedures to study protocols and associated activities
+ Prioritize activities to ensure objectives of studies/programs are met
+ Interact with Development Operations organization and supporting functions to ensure quality compliance across all aspects of clinical development;
+ Identify and mitigate potential clinical quality risks and escalate to management; Leverage knowledge of clinical development to maintain program oversight and influence proactive quality management through quality related activities; Provide proj
