Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. **Working at Abbott** According to the World Health Organization, approximately 422 million people have diabetes today and by 2045 the number is projected to rise to 700 million people. The Abbott Diabetes Care FreeStyle Libre continuous glucose monitor (CGM) sensor and customer experience delivers patient-centered solutions and empathetic experiences critical to helping people with diabetes understand how to manage their disease-state and live life to the fullest. At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: + Career development with an international company where you can grow the career you dream of. + Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. + An excellent retirement savings plan with a high employer contribution + Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s degree. + A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. + A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. **The Opportunity** The **Global** **Quality Excellence Lead** is responsible for overseeing the implementation, maintenance, and continuous improvement of Product Life Cycle Management (PLM) solutions, Training and Quality Management Systems, and reporting. This role ensures effective integration of PLM solutions into the company’s product development processes, enhancing collaboration, efficiency, and product quality. Key responsibilities include facilitating secure information sharing and collaboration between manufacturing sites, R&D, TPMs, suppliers, and the Quality function. The role also involves managing vigilance reporting solutions, including measuring, and monitoring key performance indicators to analyze trends. A significant focus is on identifying solutions to meet evolving business needs, eliminating redundant systems and processes, and automating operations to deliver business efficiencies. Additionally, the role delivers solutions that enable the business to administer company quality and compliance training effectively. This includes implementing and maintaining systems that support the creation, organization, and distribution of training content. **Core Job Responsibilities** The **Global** **Quality Excellence Lead** will lead efforts in process optimization, cross-functional collaboration, and data management, while handling various types of change orders and documentation to maintain compliance and support organizational goals. Ensuring that these systems are aligned with industry standards and regulatory requirements, the role facilitates continuous improvement and knowledge sharing across the organization. + **Strategic Insight and Best Practices:** + Contribute to the development and execution of strategic initiatives. + Develop long-term roadmaps to align business strategy with technology strategy to drive continuous improvement and innovation. + Manage project demand to ensure resources are allocated effectively. + Bring insight, knowledge, best practices, and feedback to strategic discussions to drive continuous improvement and innovation. + **Business Enablement** + Collaborative Product Development: Facilitate unified product data visibility for production planning, process validation, and quality control. + Engineering Change Management: Automate change workflows, establish review boards, and ensure traceability and compliance. + Manufacturing Process Management: Align product-to-process, manage BOM specifications, and integrate changes. + Product Data Management: Centralize control, streamline processes, and enhance collaboration with robust data management and secure access. + Supply Chain Collaboration: Unify suppliers, partners, and manufacturers with secure real-time data sharing and integrated workflows for efficient lifecycle management. + Training & Content Management: Implement and maintain systems that support the creation, organization, and distribution of company quality and compliance training. + **Relationship Management:** + Manage collaboration and partnership with Corporate Shared Services and business functions. + Align stakeholders' objectives with Corporate and Business Unit priorities to ensure cohesive project direction. + Manage conflict resolution to maintain strong business relationships. + **Team Management and Development:** + Build and manage a high-performing team, providing leadership, mentorship, and development opportunities. + Work cross-functionally on a global scale, ensuring effective collaboration and communication across different regions and departments. + **Planning and Execution:** + Develop roadmaps to guide 3-to-5 year program trajectories. + Manage projects from initiation to closure ensuring timely delivery. + Assess and analyze complex business challenges to provide insights to stakeholders. + Define functional and technical requirements to support development of business solutions. + Coordinate delivery efforts to meet project milestones and objectives. + Facilitate resolution of operational issues ensuring acceptable system testing and timely deployments in collaboration with IT and external vendors to help operations conduct business more effectively. + **Compliance and Communication:** + Communicate effectively with all levels of the organization. + Ensure adherence to relevant regulatory, corporate, and quality standards including **Corrective Actions and Preventive Actions (CAPA)** + Collaborate with legal, compliance, and cybersecurity teams to ensure data protection and privacy compliance controls are in place to protect patient data and Abbott assets. + Enable comprehensive oversight with features such as change control, document management, and closed-loop feedback. Ensure compliance and standards adherence to facilitate audits, CAPAs integration, manage customer experiences, and support traceability, while focusing on risk, reliability, and applicability. + Maintain system protocols by implementation policies and procedures in accordance with Quality Management System (QMS) policies. **Minimum Education & Qualification** + Bachelor’s degree in computer science, Engineering, or related field + 10+ years in the management and delivery of **PLM and vigilance reporting solutions.** + 5+ years of **Quality Management and Training Systems** , System Validation expertise in a regulated industry + 5+ years’ experience in **implementing global solutions** like Windchill, Oracle Agile, Veeva Vault etc. **Preferred Qualifications** + Experience in the medical device industry. + Working knowledge of data analytics and process automation. + Proven experience in managing and building high-performing teams. + Six Sigma Green Belt or Black Belt Experience **MISC:** + This is an **onsite role** located in 1420, Harbor Bay Parkway, Alameda, CA. This is not a remoter role/opportunity. Apply Now (https://www.jobs.abbott/us/en) **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx) Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott , and on Twitter @AbbottNews. The base pay for this position is $144,100.00 – $288,300.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com