Quality Regulatory Senior Program Manager

Abbott Laboratories Waukegan , IL 60079

Posted 6 days ago


At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

Abbott Rapid Diagnostics (formerly Alere) is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

We have an exciting opportunity for a Senior Project Manager-Quality. This person will manage global programs and support effective and compliant implementation of ongoing projects into Division's Quality Management System including: developing long term strategies to meet division goals, presenting program strategies and updates to executive management and stakeholders. The person will act as the Division Subject Matter Expert (SME) for quality systems and/or subsystems and/or division processes. Incumbent may be a division Process Owner for quality system processes, examples include but not limited to: production and process control subsystem SME, Validation Process Owner, Process Monitoring Process Owner, etc. The Senior Project Manager-Quality will direct multi-site, division-wide activities to accomplish quality system objectives and goals. The incumbent is the SME and may be the primary representative during internal and external inspections such as FDA, ISO, and AQR

Additional Responsibilities include:

  • Functions as the SME for a division quality system, quality subsystem, or process

  • Identifies and recruits project/program resources to support divisional scope, multi-site quality system projects/programs and manages division-level teams to achieve Division QA project/program-related goals and strategic initiatives

  • Represents and champions Division causes, products, services and quality systems to U.S. and non-U.S. regulatory bodies

  • Frequently represents Division during internal and external inspections such as FDA, ISO, and AQR

  • Interprets regulations and requirements and implements programs and procedures to meet these requirements worldwide

  • Primary division contact for domestic/international sites and affiliates regarding quality subsystems and processes

  • Collaboratively supports Directors, Quality Subsystem Owners, and other internal and/or external stakeholders with organizational, project/program management

  • Identify metrics to consistently measure program status and effectiveness of implemented solutions

  • Create appropriate messaging and dashboards to facilitate global communication to all levels of the organization

  • Forecast and communicate resource needs to ensure program success while maintaining appropriate cost levels

  • It is expected that the individual will interact frequently with Division Management with executive responsibility, and therefore requires a high level of competence, confidence and credibility

  • Strategic and tactical decisions for the Division will be made based upon the information that the individual gathers, provides and/or presents in a management setting

  • Lead global teams as appropriate for assigned Quality processes / Quality Subsystems in roles of Quality Subsystem SME / Quality System Process Owner

  • Accountable for the successful execution of business processes that have significant impact on the overall success of the business and division

  • Prepare and present written and oral reports and other presentations to internal and external audiences, including division executive staff and external customers and suppliers

  • Interact with senior level management to reach agreement regarding significant program strategies

  • Actively manages the mitigating actions to risk and resolution actions to issues with clear plans

  • Keeps up to date with Regulatory changes and guidance to ensure success for the program and projects

Required educational background:

  • Bachelors' Degree: Preferably in a science, technical and/or engineering discipline

Required experiential background:

  • Minimum 8 years In Medical Device industry or other FDA regulated industry experience

  • Experience in multiple areas of responsibility (e.g. product development, quality, operations) and working with global teams is desirable

Minimum 2 years: Abbott experience preferred

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

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Quality Regulatory Senior Program Manager

Abbott Laboratories