Global Quality I&D System and Compliance Manager - Pharmaceuticals

Job Description

JOB DESCRIPTION: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, nutrition, and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.At Abbott pharmaceuticals we are committed to bringing the benefits of our trusted medicines to more people in the world?s fastest-growing countries. We offer a broad portfolio of high-quality branded generic medicines across multiple therapeutic areas.Global Quality I&D System and Compliance Manager: A Unique OpportunityThe Individual will contribute to and supports the Abbott EPD?s Innovation and Development (I&D) efforts to create high value therapeutics to address unmet medical needs.The position will be responsible for the development and deployment of the Quality Management Systems for all EPD I&D centers, EPD regional Innovation hubs, Global Pharmacovigilance, Global Regulatory Affairs, Global Medical Office and extended external partner network.This role will support quality improvement plans / initiatives across the EPD I&D global network, and it will be responsible for the I&D site assessment and inspection readiness, I&D GxP Internal audit program.WHAT YOU?LL DO

• Responsible for developing, deploying, managing, and continuously improving an Abbott Quality System in I&D which drives global compliance and is appropriate for the organization and product portfolio.
• Reviews and simplify existing Global policies and Global procedures, identifies gaps, and supports the development and communication of new and enhanced Global policies and Global procedures leading to compliant I&D operations. Assure effective training is carried out to build a knowledge excellence for I&D organization.
• Responsible for implementing and maintaining a performance metric and management review process.
• Provide expert knowledge of global regulations and guidance, corporate and division standards and support the implementation of quality improvement plans / initiatives across the EPD I&D worldwide network.

Compliance

• Liaise with functional and other Quality teams and stakeholders as appropriate to ensure global and local coverage of inspection readiness activities as they pertain to the Quality Systems for I&D centers, regional Innovation hubs and extended external partnership network.
• Ensures monitoring of I&D operations to identify potential compliance risk areas; recommends and assists with the implementation of enhancements to existing policies and procedures and other corrective actions.
• Provide oversight and support at I&D centers to deploy corporate and divisional program like Data Integrity Assurance and Cybersecurity

Leadership

• Ensure the timely execution of defined goals and associated deliverables.
• Promote innovation and continuous improvement culture within the business.
• Support a learning culture that fosters right first-time quality principles and best practice sharing.

EDUCATION AND EXPERIENCE, YOU?LL BRING

• Bachelor?s Degree in chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area.
• Comprehensive understanding of development and manufacturing of pharmaceutical and non-pharmaceutical products (including food supplement and cosmetics).
• 5+ years pharmaceutical drug development or Quality Assurance or Compliance experience
• Knowledge of international GxP drug development regulations, including ICH guidelines and ISO standards.
• Capable of understanding and overcoming different cultural and language obstacles to provide solutions that satisfy corporate, regional, and local objectives.
• Excellent verbal and written communication skills in Business English.
• Excellent knowledge of data integrity regulations and requirements.
• Flexibility to adapt to changing assignments and ability to effectively prioritize and timely execute defined goals and associated deliverables.
• Capable of understanding and overcoming different cultural and language obstacles to provide solutions that satisfy corporate, regional, and local objectives.
• Ability to travel across all geographies.
• Travel amounts no less than 60% /year

Desired: Master?s degree in chemical, Physical or Biological Sciences. ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or other International certification. Project management skills and knowledge of foreign language like Russian or Spanish is a plus.Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us atwww.abbott.com,on atwww.linkedin.com/company/abbott-/, onFacebook athttp://www.facebook.com/Abbottand on Twitter@AbbottNews.JOB FAMILY:Operations QualityDIVISION:EPD Established PharmaLOCATION:United Arab Emirates > Dubai : Dubai Airport Freezone, Building 5WA, Floor 8ADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 50 % of the TimeMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Not Applicable

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