Abbott SR CLINICAL QUALITY ASSOCIATE in Sylmar, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
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.
This position could be located in our Plymouth MN, Sylmar CA, Sunnyvale CA or Burlington MA office locations.
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 SJM 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
Bachelor’s 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
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@example.com