US National – Telecommute
Senior Manager, Quality Systems – Consumer Services & Products-REQ19030066
Snr. Manager, Quality Systems- Consumer Services & Products
DO WORK THAT MATTERS
Alere is now part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. As we embark on this exciting journey, our Rapid Diagnostic Division is searching for a dynamic, self-motivated, Med Device and/or Diagnostics industry Quality Systems expert to be responsible for establishing and maintaining an efficient Quality Framework, which reflects the vision, mission, and expectations of the Consumer Services and Products Business Unit (BU). In this newly created, cross-BU functional opportunity, and as a member of the BU QA/RA team, this position supports and promotes BU quality and regulatory strategy and fosters a collaborative relationship with ARDx (Division) QA/RA, and all levels of the BU, to ensure efficient processes that align with Division and Abbott Quality and Regulatory (AQR) policies and procedures. The position will build, manage and work with a small team of quality professionals, necessary to implement and maintain a BU Quality Framework, that provides oversight, measurement and monitoring of BU quality and regulatory performance.
If you possess a strong ability to engage/work with BU stakeholders, as well as site quality leaders and have a mastery of data necessary to influence fact/risk-based decisions to demonstrate measured outcomes, come work with us!
Lead the formation of the BU Quality Framework and team, considering the diverse needs of contract manufacturing, distribution and home health care service entities.
Participate with Division, BU and site leaders to align on processes that should be shared at Division level vs. those that should align to AQR/Division Policy at BU or site level.
Translate general BU quality objectives into concrete strategic and tactical plans.
Establish and maintain a BU Risk Management process, ensuring a Risk Register is periodically reviewed and maintained with significant risks reported to the BU Senior Leadership Team.
Develop mechanisms to deploy framework to all impacted sites, assess compliance gaps, and facilitate remediation activities, where necessary, utilizing risk-based prioritization.
Highly adaptable and receptive to working in a fast-paced, constantly changing work environment,
Solid team skills, able to effectively motivate cross-functional, virtual teams and lead or delegate, as required, to ensure achievement of team and project objectives,
Strong influencing and persuasion skills, and ability to instill confidence in others,
Results oriented mind-set, with excellent analytical skills and the ability to translate complex technical and regulatory requirements into efficient business processes,
Carries out duties in compliance with established BU and AQR practices, policies and processes,
GOVERNANCE & PERFORMANCE MANAGEMENT
Lead quarterly BU Management Reviews, reporting on implementation status and performance of the BU Quality Framework and systems.
Manage BU quality metrics, including required reporting of BU data for Abbott Monthly Reviews (AMR), and perform trending and analysis to inform BU quality objectives, priorities, and improvements.
Monitor BU external and internal inspectional results, assessing BU performance trends, sharing relevant information across the BU, and supporting entities, in defining appropriate corrective actions.
Support BU entities in the appropriate elevation of quality and regulatory actions (e.g. field actions), consistent with AQR/Divisional policies and procedures.
Implement process to periodically assess BU entity compliance with AQR, Division and BU policies and procedures.
7+ years medical device industry experience and/or Joint Commission health care sta…
Customer Service , Project Management