• Project Manager, Global Affiliate Compliance

    Abbott (Alameda, CA)


    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.

     

    Project Manager, Global Affiliate Compliance

     

    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.

    + Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

    + 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

     

    Responsible for driving CAPA projects through its entire lifecycle, working closely with Commercial Affiliates. Communicates project updates and identifies areas for improvement while defining / implementing solutions as the key contact for new or updated process requirements to the Commercial Affiliate organization. This role will also be responsible for reviewing, updating, and maintaining Commercial QA KPIs, while providing strategic input to contribute to overall business efficiency. Other responsibilities may include providing support on any other improvements related to Commercial Affiliate processes when necessary.

     

    This position will be based out of Abbott Diabetes Care in Alameda, CA and the individual will be expected to be onsite Monday-Friday.

    What You'll Work On

    + Manage activities associated with product-related projects by coordinating the activities from key functional areas.

    + Evaluates and progresses timely completion of CAPA activities raised for Affiliate related divisional nonconformances, potential nonconformances, and/or deviations.

    + Maintains the effectiveness of the CAPA system records to ensure divisional audit readiness for internal and external quality system audits.

    + Provides guidance and necessary support for Commercial Affiliates in the management of their CAPA actions to ensure completeness and conciseness; and that viable corrective actions are identified and implemented to address any non-conformances.

    + Drive the Management Review process for Commercial Affiliates at the Divisional level.

    + Responsible for the implementation of Quality metrics necessary to streamline processes for optimal efficiency and capture Quality data for use in Quality Management Review presentations.

    + Implement process improvements to support the division to achieve its long-term goals.

    + Responsible for implementing and maintaining the effectiveness of the Quality System.

    + Support any other Commercial QA team activities, as required.

    Required Qualifications

    + Bachelor’s Degree, preferably in Technical Field, Life Sciences, or closely related discipline. Master's Degree preffered.

    + Equivalent combination of education and work experience.

    + Minimum 3-5 years of relevant experience in Quality Systems or Quality Assurance.

    + CAPA experience and demonstrated use of quality tools / methodologies.

    Preferred Qualifications:

    + Experience working with international businesses.

    + Strong organizational and follow-up skills.

    + Ability to multi-task and prioritize multiple deadlines.

    **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.

     

    Divisional Information

     

    Medical Devices

    General Medical Devices:

    Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

     

    Diabetes

     

    We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

     

    The base pay for this position is $86,700.00 – $173,300.00. 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 [email protected]