Senior Associate Clinical Quality

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 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 student debt program, and FreeU 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

This position of Senior Associate Clinical Quality, works out of our Lake Forest, IL location in AMD , Abbott Molecular Diagnostics. Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to life’s critical health decisions. We help people live full and healthy lives through our accessible, molecular-based solutions.

What you will do

Provide global support to Clinical Development (CD) staff to ensure compliance with company policies, GCP regulations/guidelines, ISO standards, and other applicable requirements. Clinical Study Support: Act as a reviewer of protocols, informed consent forms, case report forms and other essential study
documentation for product and process changes, offer overall support to project teams in order to eliminate compliance risks; and
Represents Clinical Quality at project / protocol deviation meetings to maintain and promote quality and compliance within CD.

Compliance & Training

• Advise CD staff on GCP guidelines, ISO standards, and departmental procedures.

• Facilitate departmental training sessions.

• Coordinate internal Continuous Improvement Detection (CID) and CAPA processes, including approval of proposed actions and follow-up until closure.

• Drive continuous improvement initiatives across CD.

Clinical Study Support

• Review protocols, informed consent forms, case report forms, and other essential study documents for product and process changes.

• Provide compliance risk mitigation support to project teams.

• Represent Clinical Quality in project and protocol deviation meetings to promote quality and compliance.

Audit & Inspection Support

• Assist project teams and investigational sites in preparing for AQR audits or regulatory authority inspections.

Required Qualifications

• Bachelors Degree Preferably in Life Sciences

• Minimum 5 years medical devices, clinical research experience, or related industry.

Preferred Qualifications

• Prefer at least 3 years of related work experience in Quality role in medical device area and/or clinical trial environment.

• Prefer GCP audit experience. Specific requirements:

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

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.

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The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.