Manager, Quality Compliance

Description

Manage all routine activities of Quality Compliance functions to assure overall compliance to FDA current Good Manufacturing Practice (cGMP) regulations for activities related to testing and release of all drug substances, components, and packaged product. Assure plant wide compliance to cGMP’s in concert with and as directed by the Site Head - Quality and provide back- up to the Site Head - Quality in their absence. 

Job Responsibilites

• Manage all routine activities of Quality Compliance functions to assure overall compliance to FDA current Good Manufacturing Practice (cGMP) regulations for activities related to testing and release of all drug substances, components, and packaged product.
• Assure plant wide compliance to cGMP’s in concert with and as directed by the Site Head – Quality.
• Ensure the efficient flow of drug substance components though the Quality Control Laboratory to release of raw materials and bulk product.
• Job specific training for all Quality Control laboratory and Quality Assurance personal engaged in testing and release of active pharmaceutical ingredients.
• Implementation of the cGMP training program for all Chattem Chemical Quality Assurance and Operations personnel.
• Participates in FDA facility Audits.
• Interface with purchasing departments on any quality related issues with Intermediates, Raw Materials or APIs.
• Interface with Processing, manufacturing, and analysis groups.
• Interface with IT to ensure IT and site are compliant with cGMP and FDA expectations.
• Develop and maintain or assure that adequate training programs are in place for all Quality Assurance/ Quality Control personnel engaged in the testing and release of components, bulk finished products and packaged APIs.
• Develop and maintain the plant wide cGMP training program.
• Assist in the development and management of Quality Compliance department operating budget; Assist in the development of the Quality Assurance.
• Quality Control capital budget in support of ongoing operations and new initiatives; assurance that capital budget initiatives are executed to support department objectives.
• Assist in laboratory analytics including volume and through- put analysis, deviations, OOS and investigation metrics.
• Maintain awareness of compliance initiatives relevant to areas managed. 
• Serves as a member of the site audit team and conducts inspections of Chattem Chemicals contract suppliers. 
• Review and approve laboratory out of specifications investigations. Conducts investigations into drugs substance components or drug substance failure as needed or directed by the Site Head - Quality.
• Review and approve operational quality documentation such as environmental monitoring, cleaning, calibration, equipment operation and maintenance related to the internal manufacturing and analytical laboratories. 
• Collaborate with customers to ensure quality systems are monitored and established metrics are met. 
  Provides support during regulatory agency site inspections. 
• Serves as back- up to the Site Head - Quality in their absence.
• Other duties, as assigned.

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 programs to include Word, Excel, Access and Power Point. 
• Proven history of Compliance improvements.