.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 www.Abbvie.Com.
Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.Job DescriptionThe Affiliate Sr. QA Manager is responsible for providing leadership and oversight of Quality Compliance matters at an operational and regulatory complex commercial entity or multiple commercial entities in support of the quality system requirements associated with pharmaceutical products, medical devices, combination products and biologics.
Specific areas include Storage and Distribution, Product Complaints, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, Lab Controls, CAPA, and overall Quality Manual requirements.
This position will ensure that all product, process, or system related quality activities supporting the business from receipt through shipment of final product are in compliance with Corporate, governmental, and local regulations.Responsible for the integration and support of quality regulations: drug, biologics, device and/or combination products driving the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.Responsible for the management and oversight of a large team or multiple teams including hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues.
Ensuring adequate resources and appropriate training to effectively support and meet changing business and compliance needs.Establish training requirements and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance.Lead and oversee support activities related to product actions in the affiliate.Assure key metrics are being monitored and met to ensure compliance and to drive continuous improvement including review of procedures and process to identify areas of opportunity.Partner with stakeholders across the enterprise to gain a better understanding of processes external to QA to determine best steps forward.Responsible for partnering and overseeing support activities related to product actions in the affiliate.
Oversee coordination and investigation of key quality systems (ie.
CAPA, product complaints) ensuring KPIs are being met.Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements