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.
Primary Job Function:
Independently conducts assigned audits of Suppliers and Third-Party Manufacturers (TPM) to assess compliance to all applicable External Standards and Regulations as well as Abbott Quality System requirements at a standard commensurate with regulatory external audits. May participate in audits of manufacturing and commercial affiliate sites; involved in projects that are cross-functional/cross-divisional in scope as Subject-Matter-Expert (SME).
Core Job Responsibilities:
Independently conducts and leads audits across ADD's Supplier and TPM network.Identifies compliance risks to current standards / regulations and may guide in the planning and execution of Quality System improvements.
Ensures compliance to Division and Corporate policies and procedures by promptly reporting non-compliance issues
Participates as SME in audits; provides compliant, and strategic solutions to complex quality issues.
Leads projects that are cross-functional in scope; directly influences project direction and scope; champions new initiatives and acts as the catalyst for change within and potentially across Divisions
Maintains and demonstrates understanding of global standards, regulations and regulatory bodies
May assume managerial responsibilities as needed
Reports to Manager, Global Compliance and Auditing
Yes, 40% global travel
Degree preferably in science or technical discipline such as biology, chemistry, engineering, or closely related discipline .
Minimum Training /Experience
Trained in Auditing techniques; Certified Auditor qualification or equivalent is required. Trained at a minimum as a Certified Auditor with working knowledge of Good Manufacturing Practices (GMPs), Quality Systems standards and regulatory requirements such as 21 cfr 820, 21 CFR Part 600, ISO 13485 and IVDD.
Minimum of 8 years experience in pharmaceutical or medical device industry or other regulated industry.
Location is open; desired locations: Dallas, Chicago or Santa Clara.
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 or email