Abbott Director, Commercial Compliance in Austin, Texas
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.
Provides strategic and tactical business leadership for the development and implementation of compliant documentation and solutions, processes and strategies that meet customer needs and conform to established Abbott standards and applicable regulatory requirements.. Drives quality improvement projects and initiatives in area of responsibility. Works with corporate teams and influences Abbott quality positions and interpretation of US regulations. Responsible for Commercial Quality Assurance to include compliance with all regulatory requirements, ISO and HACCP standards and customer expectations.
• Provide strategic direction and oversees tactical execution of quality initiatives within the Commercial teams to assure the long-range success of the organization and the integration of quality process systems across the US business.
• Acts as the liaison for the Commercial organization to coordinate product quality issue resolutions with Medical, Regulatory Affairs, Legal, Operations, Materials Management, Purchasing and Engineering.
• Provide oversight to disposition of high risk product non-conformance situations; assure adequate investigation and corrective action systems are in place to prevent future occurrences.
• Planning and implementation of division-wide projects related to to achieve Commercial adherence with quality and compliance requirements/ objectives.
• Optimization of processes and organization to effectively and efficiently deliver commercial business needs to meet and sustain key business initiatives and net sales and profit goals for the division globally.
• Assure staffing and leadership continuity through talent management succession planning and developmental moves. Create a diverse organization and encourage diversity within the organization.
• Directly responsible for the interface with the Commercial organization to coordinate education, training, adoption and compliance of all quality processes and procedures.
Bachelors Degree (± 16 years) Science, Engineering or Business
an equivalent combination of education and work experience
Minimum 5 years QA Management experience or related
Minimum 5 years Supervisory experience
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