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** At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists **The Opportunity** This position has responsibility to establish and maintain quality assurance programs to drive alignment of policies, processes and develop appropriate quality plan objectives to ensure the global Core Diagnostics division has a suitably effective Quality System that conforms to all established regulatory requirements and standards. This includes ensuring appropriate clarity of quality roles and responsibilities across Core Diagnostics manufacturing sites and Business Units, ensuring alignment, appropriate quality agreements and clear approaches to strategic compliance are understood and communicated as necessary across Core Diagnostics Global QA Functions as well as its various Business Units. The incumbent is the designated Core Diagnostics Subject Matter Expert for Global Quality Systems, serving as an expert contact during internal and external inspections of the division establishment, and supporting similar inspections and audits across sites and business units within the division. Leads all inspection readiness strategies and guides site compliance functional resources for Global Core Diagnostics. Provides guidance, best practices and communications to influence across sites and functions, ensuring QS metrics and monitoring are established and reported, as well as reviewing and determining when to react to potential quality trends. Interprets and recommends modifications to division and site policies and practices as needed, ensuring alignment to corporate quality policies. Balances inspection readiness activities with business priorities and quality plan objectives, while determining appropriate corrective actions and solutions to recommend to division, business unit and site leadership as appropriate. Makes decisions that translate programs from top management into operational plans and schedules; monitors and reports on progress and identifies goals to meet and maintain compliance certification status as necessary to support Core Diagnostics business strategies. **What You’ll Work On** + Interacts with senior management and external agencies/regulators concerning matters of quality compliance and quality system requirements for the Core Diagnostics division. Develops quality goals to support business strategies, aligned across functions in the organization, and ensures the quality plan objectives are carried out and reported on to key management. + Provides overall leadership for Quality policies, approaches, and standard practices. Maintains alignment with US and International regulations and standards, as well as Abbott quality systems. + Monitors and ensures compliance with FDA, ISO, IVDR regulations, and other regulations and standards as applicable; is responsible for internal audits for Global Core Diagnostics sites and businesses to ensure a robust program of oversight is in place, performed and reported on to key management. + Responsible for leading multiple quality system elements and ensuring accessibility to tools, templates and training. + Responsible for the success of quality and regulatory inspection preparedness through establishing and overseeing a multi-faceted strategic compliance approach for the division, business units and manufacturing sites. Provides compliance and inspection readiness tools and direction across the organization as necessary to drive alignment and visibility of progress. + Evaluates staffing capabilities for people performing key audit support roles; works to share best practices, builds capabilities and guide learning for these resources to achieve business goals and compliance requirements across Core Dx. + Responsible for ensuring functional areas of responsibility have adequate skills and training to address the areas of responsibility, including Division Quality Systems Change Control, QS Monitoring, Management Review, Internal Audits, Training and Strategic Compliance to ensure corporate QS requirements are met. + Establishes and implements necessary communication strategies for the improvement and awareness of quality improvements as needed to build a quality culture and ‘Always Inspection Ready’ mindset. + Identifies and builds appropriate team to support Core Dx Global Division support, alignment across all business units within Core Dx, and has dotted-line authority with all BU and site QS leads. This is to be maintained through establishing appropriate process communities to drive sustainability in key QS areas and ensuring appropriate awareness and focus is directed to AMR Metrics and key QS KPIs. + Responsible for department financials and developing cost improvement ideas and strategies in coordination with other division functions. + Fosters a diverse workplace that enables all participants to contribute to their full potential and develops strong internal partnerships in pursuit of organizational objectives PRRC (Person Responsible for Regulatory Compliance) and Site Quality Head responsible for Third Party Manufactured IA/CC Reagents. **Qualifications** + Bachelor’s degree required in a scientific or technical discipline + Minimum 10 years required in quality or a related field + Minimum 6 years required of direct management experience in QA, Quality Systems, Internal Auditing or Compliance + Demonstrated knowledge and experience in a diagnostics or medical device related discipline and/or business, preferably with experience in additional functions of the business such as Operations, Engineering and/or product technical support 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 and @AbbottGlobal The base pay for this position is $168,000.00 – $336,000.00. 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