eConsultAmerica is a preferred vendor supplier on retainer with a major global supplier of health products with the oldest, best known and most respected health products in the world. Our client is seeking an experienced and savvy Manager of Manufacturing Quality Assurance who will be responsible for management of QA Line operations, Receiving Inspections, Quality Engineering and Supplier Quality performance improvement processes to ensure FDA and ISO Compliance. This position will be based in Greenville, SC. Relocation Package is available and offered to highly qualified candidates. If you are interested please forward a brief cover-letter and your updated resume and I will respond back within one (1) business day. US Citizens or Green Card holders only apply.
The IDS Center
80 South 8th Street, Suite #900
Minneapolis, MN 55402
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The chosen candidate will be 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. This position requires a strong background in Pharmaceutical or Medical Device Quality Management. H/She will insure the reporting of timely and detailed non-conformance investigations. Requires demonstrated root cause analysis, investigation and technical 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. Candidate will provide leadership to Operations on cGMP and other compliance requirements. Previous experience as a direct interface during FDA inspections is a plus.
Manage MQA line inspection supervisors, including receiving Inspections, Quality Engineering, and Supplier Quality functions to ensure continued compliance with site, Global and Regulatory requirements.
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. Candidate will use Lean/Six Sigma tools to support manufacturing in identifying areas of improvement.
BEST INDUSTRY – Healthcare
BEST DEPARTMENT – Quality Assurance
Bachelors Degree in Chemistry, Microbiology, Biology or related scientific discipline is required.
8+ years experience 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.
Experience and working knowledge of FDA, ISO, EU requirements are a plus.
Experience and working knowledge of ICH, WHO, PIC/S guidance and regulations are a definite ++.
Demonstrated knowledge of management of Quality operations and processes.
Demonstrated technical writing ability and proficient computer skills are required.
Demonstrated success in the cultivation and development of direct reports.
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.
Experience and demonstrated proficiency with Minitab, Matlab, Statistical, JMP, SAS or similar programs are a definite ++.
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.
Six Sigma BB or MBB are a definite ++.
80K – 100K