Job Description:
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Job Description
Reporting directly to the Site Quality Director. Responsible for management of QA Line operations, Receiving Inspections, Quality Engineering and Supplier Quality performance improvement processes to ensure FDA and ISO Compliance for Greenville Operations. Reporting directly to this position will be two Manufacturing Quality Assurance Shift Supervisors and one Quality Engineer. Requires a strong background in Pharmaceutical or Medical Device Quality Management. Ensure detailed, thorough investigations are completed to current industry expectations and in a timely manner. Requires demonstrated investigation and report-writing skills. Responsible for staff development to focus on process improvement and the use of basic and advanced quality engineering tools such as SPC and DOE. Will provide leadership to Greenville Operations on cGMP and other compliance requirements. Previous experience as a direct interface during FDA inspections is a plus.
Job duties include, but are not limited to:
Manage MQA line inspection supervisors, including receiving Inspections, Quality Engineering, and Supplier Quality functions to ensure continued compliance with site, Global and Regulatory requirements. Includes staff development.
* Ensure Material and Quality System investigations and technical issues are resolved in a timely manner and in compliance with current agency and industry standards. Propose and implement systemic corrective actions.
*Lead Supplier Management Team (SMT) with the goal of driving continuous improvement in supplier quality performance and to support timely resolution of supplier nonconformance issues.
*Uses Lean/Six Sigma tools to support manufacturing in identifying areas of improvement. Qualifications Education:
*Minimum of a B.S. degree in Engineering (chemical or mecahnical preferred) or related scientific discipline.
Experience:
*Significant experience (8+ years) managing quality systems in a sterile pharmaceutical or medical device facility.
*Experience as an internal or external auditor and in conducting investigations.
*Experience as direct interface with FDA during inspections a plus.
*Exposure to global regulations a plus.
Special Skills:
*Demonstrated knowledge of management of Quality operations and processes.
*Demonstrated technical writing ability and computer skills are required.
*Demonstrated success in leading and developing Quality professionals.
*Strong analytical and problem solving skills especially in non-conformance investigations.
*Ability to assertively interact with people at all levels of the organization.
*Ability to manage multiple priorities.
Specialized Training:
*Specialized training in 21CFR211, 21CFR820, ISO 13485:2003 preferred.
*Training in aseptic or other sterilization systems. PDA courses in aseptic manufacturing helpful.
*Quality Engineer Certification highly desired. Work
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