US: Manager, Quality Assurance
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Manager, Quality Assurance
* Manage all QA areas within Reference Standard activities. These include the following: Investigations, Laboratory, and Customer Complaints
* Manage the following QA systems:Investigations, Customer Complaints, Reference Standard Evaluation Process
* Prepare and assist in managing the following QA activities:ISO 001:2008 certifications; ISO 17025:2005 accreditation; Guide 34 accreditation
* Track and trend different elements of the quality system and report on the progress of the programs, including areas of strength and opportunities for improvement on a monthly basis.
* Provide QA guidance for the review and disposition of all deviations, lead investigations, review customer feedback, and CAPAs, including working with other functional areas on closure. Assist staff with corrective action and issue follow up.
* Suggest opportunities for improvement consistent with improved business practices and appropriate preventive actions. Provide data and recommendations for QMS/LQMS reviews
* Be the point of contact for the Customer Experience/Customer Complaint System once in place
* Lead process improvement teams and long term projects
Bachelor's degree and 7-10 years relevant experience in a pharmaceutical, biotech, or other regulated industry. Minimum 7 years QA experience. Must have at least 2 years of supervisory experience.
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Team SQAFYI - Software QA Resource FYI