Manager, Clinical Quality and Compliance

at  Abbott Laboratories

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.

REQUIRED QUALIFICATIONS:

• BS/BA degree in science or related field.
• 8+ years’ experience in Good Clinical Practice (GCP) and/or Quality Assurance Environment, including 5+ years clinical study/project management experience
• Broad knowledge of IVDR, ICH, GCP, IRB/IEC, and local regulatory authority for diagnostic & assay development regulations.

PREFERRED QUALIFICATIONS | EDUCATION/EXPERIENCE:

• Master’s degree preferred.
• At least 2 years of management experience in a similar role.
• Prior experience managing clinical trials for or within the biotech or device industry, including CRO management, clinical site monitoring, and knowledge of the basic data management processes.
• Ability to work within established timelines, in a fast-paced environment.
• Prior IVDR/IVD experience/Clear understanding of relationship of diagnostic test results to patient clinical diagnosis/treatment
• Proven leader with passion and skills for strategic and critical thinking, problem solving, motivating and mentoring team members
• Ability to understand strategic goals and match to the business needs of the company.
• Ability to independently manage and provide significant tactical leadership and guidance.
• Excellent matrix leadership.
• Embody a culture of improvement and progress; promote knowledge sharing.
• Strategic thinking and analytical skills. Strong written and verbal communication skills.
• Superior organization skills with excellent attention to detail.
• Excellent computer skills and knowledge of Microsoft Office and the ability to learn appropriate software.
• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
  Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
  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 $83,000.00 – $166,000.00. In specific locations, the pay range may vary from the range posted

Please refer the Job description for details