Job Description

Job Description Management and oversite of Quality Assurance roles and responsibilities; including yearly goal setting, mid-year and end-of-year reviews, and other managerial requirements needed for direct reports. Job specific training for all Quality Assurance personal engaged in release of active pharmaceutical ingredients. Implementation of the cGMP training program for all Chattem Chemical personnel. Participates in FDA inspection Preparation. Interface with purchasing departments on any quality related issues with Intermediates, Raw Materials or APIs. Ensure overall compliance of Quality Assurance/Quality Control activities and plant operations related to manufacturing, testing, and release of all components, bulk finished products, and packaged API’s. Assist in the development and management of Quality department operating and capital budgets in support of ongoing operations and new initiatives; assurance that capital budget initiatives are executed to support department objectives. Provide leadership, training, and development opportunities to Quality Assurance roles in order to enhance team skills and performance. Maintain awareness of compliance initiatives relevant to areas managed. Develop Standard Operating Procedure applicable to areas managed, understand and interpret Standard Operating Procedures governing all aspects of plant operations including area not under direct control. Maintain awareness of new cGMP initiatives affecting Quality operation under the purview of Site Head – Quality. Serves as a member of the site audit team and conducts internal inspections of Chattem Chemicals. Reviews and approves investigations. Conducts investigations into drug substance components or drug substance failures as needed or directed by the Site Head – Quality. Reviews and approves operational quality documentation such as environmental monitoring, cleaning, calibration, equipment operation and maintenance related to the internal manufacturing and analytical laboratories. Ensure quality systems are monitored and established metrics are met. Provide support during regulatory agency site inspections. Assists in dispositioning of rejected materials. Serves as back-up to the Site Head – Quality in their absence. Provide support during routine customer site audits. Maintain site certifications such as Halal, Kosher, HACCP, Etc. Manage and ensure the validation program is functioning as intended. Serves as back-up to the Manager of QA Compliance in their absence. Manage and ensure the APQR program is functioning as intended. All other activity instructed from time to time. Requirements Advanced degree in Chemistry or related field with at least 5 years in quality assurance/ quality control. No less than 5 years Quality Control/QA experience in a cGMP/API environment. Previous management experience. Exceptional user of Microsoft Office Suite, to include Word, Excel, Access and Power Point. Proven history of Compliance improvements.

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