Paul Rice Email & Phone Number | Senior management executive with proven leadership experience in planning, organizing, and managing quality assurance and regulatory affairs functions in the pharmaceutical, medical device, and biotechnology industries. Remediation of regulatory compliance issues with FDA and other international health authorities. Process focused, hands-on team builder with domestic and international experience in the management and operation of multiple plant locations. Solid communications with individuals at all organizational levels. •Remediation of Quality Systems in resolving FDA Warning letters and FDA 483 Observations. •Providing leadership and strategic guidance for global quality assurance and regulatory affairs operations. •Development and validation of aseptic manufacturing processes for pharmaceutical and biotechnology products. •Development and implementation of quality systems and quality policies for manufacturing class II and class III sterile medical devices. •Implementing, ISO 9001/2000, ISO 13485, GMP/QSR, GCP, GLP compliant quality systems •CE certification process for international marketing and distribution of medical devices •Developing and managing OEM support for manufacturing medical devices and pharmaceutical products •Developing and coordinating IDE, PMA, and 510(k) submissions for U.S. FDA approval •Leadership in implementing Six Sigma, Lean Six Sigma, Business Process Improvement, Continuous Improvement, Total Quality Management, and Just In Time manufacturing processes

Paul Rice

Senior management executive with proven leadership experience in planning, organizing, and managing...
Woodstock, Illinois, United States

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Paul Rice’s Email paul.rice@avalign.com

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Paul Rice’s Location Woodstock, Illinois, United States

Paul Rice’s Current Industry Avalign Technologies

Paul Rice’s Prior Industry Stryker Sustainability Solutions

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Work Experience

Avalign Technologies

Vice-President Regulatory Affairs and Quality Assurance

2013-09-01 00:00:00 - Present

Stryker Sustainability Solutions

Vice-President Quality Assurance and Regulatory Affairs

2008-01-01 00:00:00 - 2013-02-01 00:00:00

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FAQ About Paul Rice

Paul Rice is located at
Woodstock, Illinois, United States

Paul Rice is a Senior management executive with proven leadership experience in planning, organizing, and managing quality assurance and regulatory affairs functions in the pharmaceutical, medical device, and biotechnology industries. Remediation of regulatory compliance issues with FDA and other international health authorities. Process focused, hands-on team builder with domestic and international experience in the management and operation of multiple plant locations. Solid communications with individuals at all organizational levels. •Remediation of Quality Systems in resolving FDA Warning letters and FDA 483 Observations. •Providing leadership and strategic guidance for global quality assurance and regulatory affairs operations. •Development and validation of aseptic manufacturing processes for pharmaceutical and biotechnology products. •Development and implementation of quality systems and quality policies for manufacturing class II and class III sterile medical devices. •Implementing, ISO 9001/2000, ISO 13485, GMP/QSR, GCP, GLP compliant quality systems •CE certification process for international marketing and distribution of medical devices •Developing and managing OEM support for manufacturing medical devices and pharmaceutical products •Developing and coordinating IDE, PMA, and 510(k) submissions for U.S. FDA approval •Leadership in implementing Six Sigma, Lean Six Sigma, Business Process Improvement, Continuous Improvement, Total Quality Management, and Just In Time manufacturing processes