Manager, Manufacturing Quality Assurance - (US-SC-Greenville)
Manager, Manufacturing Quality Assurance - (US-SC-Greenville)
Compensation: $80K - $100K / Year
Minimum Education: Bachelors
Job Type: Full Time
Jobcode: LB4049BRJA
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Experience Required : 5 - 10 years
Degree Required : 4 Year Degree
Travel Required : to 25%
PAID RELOCATION AVAILABLE
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. Ensures 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. Will provide leadership to Greenville Operations on cGMP and other compliance requirements. Previous experience as a direct interface during FDA inspections is a plus. Certification as a Six Sigma GB or BB are a definite 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 Chemistry, Microbiology, Biology or related scientific discipline.
• Technical Degree (e.g. Statistics, Engineering) are a definite plus ++.
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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.
• Experience and working knowledge of FDA, ISO, EU requirements are a plus.
• Experience and working knowledge of ICH, WHO, PIC/S guidances and regulations are a definite ++..
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Special Skills:
• Demonstrated knowledge of management of Quality operations and processes.
• Demonstrated technical writing ability and proficient 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.
• Experience and demonstrated proficiency with Minitab, Matlab, Statistica, JMP, SAS or similar programs are a definite ++.
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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.
• Six Sigma BB or MBB are a definite ++.
Candidate Must Have :
* pharmaceutical manufacturing
* BS degree
* quality assurance
* management
Email resume in Word to thebiggamehunter@cisny.com. Please include the job code for the position with your resume.
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posted by Unknown at 9:47 AM
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