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 103,000 colleagues serve people in more than 160 countries.
The Sr. Clinical Quality Specialist provides leadership and direction to and works with Global Clinical customers to develop, re engineer and maintain the Quality System Processes, Procedures, and tools to ensure compliance with applicable US and International standards and regulations. Auditing institutions, contract research organizations, and Abbott Clinical operations associated with clinical trials, studies and investigations to identify regulatory and business risks. Supports external audits and inspections.
Ensures Clinical compliance to applicable US and International standards and Regulations by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements.
Perform audits of institutions, contract research organizations, and Abbott Clinical operations associated with clinical trials, studies and investigations to identify regulatory and business risks.
Maintaining and documenting the business process within the Quality System framework and the document management system.
Preparing project and process documentation consistent with standards and procedures outlined in the Quality System documentation
Evaluation of regulations and ability to translate requirements into user friendly Standard Operating Procedures and Work Instructions.
Works under only very general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy
Bachelorís degree in Business, Scientific or related field
Minimum of five to seven years of Clinical Research experience, industry experience preferred
Five to seven years business analyst experience or equivalent gained through a combination of formal training and progressive work experience, including project management experience
Prior work experience with ISO 14155 and 13485 and US 21 CFR is required
Excellent communication and customer service skills required
Previous leadership and team motivation skills to manage work timelines that requires effective delivery to internal Abbott customer
Previous experience successfully working in a cross functional heavily matrixed work environment
MBA or Advanced degree preferred