The Quality Manager is responsible for developing, assigning responsibility, implementing and monitoring the site Quality Plan.  This includes delivery of training and execution of methodologies to enable the manufacturing site to deliver consistent, safe and effective products.   Responsible for managing the site’s Quality Audit Program to ensure conformance with standards and Quality-related regulatory requirements.  The individual will also leverage audit results and other data based Key Performance Indicators (KPIs) to identify and drive continuous improvement opportunities and reduce variation and waste.

Required Qualifications:

• Bachelor's Degree (or equivalent university degree) in Chemistry, Microbiology, Biochemistry, Engineering or related field.
• At least 10 years of experience in Quality, Supply Chain or Research & Development 
• At least 5 years of experience in a Manufacturing/Plant Operations environment 
• At least 5 years of experience conducting and facilitating effective Failure Investigations, Corrective and Preventive Action, Notices of Deviation and Management of Change Documentation 

Preferred Qualifications:

• At least 5 years of experience in a regulated industry i.e. FDA, EPA or OSHA 
• Direct experience with active participation in an FDA or EPA inspection of a site is required. 
• Experience in a leadership position for hosting an FDA or EPA inspection is highly desired. 
• 2 years using statistical tools such as Minitab, SPC 
• 5 years of supervision experience 
• 2 years of experience in a Technology Transfer role 
• Experience using SAP or other plant-related computer systems