Total 2 Public Relations Manager job vacancies in The United States of America

     

JOB DESCRIPTION:

MAIN RESPONSIBILITIES
ㆍEnsure a Quality system is in place in compliance with Regulatory and ISO standards
ㆍLead QA organization (HC 20~30) to implement compliance, supplier quality, design quality, change control and internal audit, Post market surveillance
ㆍExpertise in ISO, GMP international standards
ㆍMake release decisions of finished products
ㆍLead Quality Management Remediation Project  to meet Abbott quality standards
 
 
QUALIFICATIONS
 
ㆍOver bachelor degree in relevant major (Knowledge on diagnosis mechanism (Biological, Immunization)
ㆍLeadership experience in quality systems (> 10 years) in Pharmaceutical , medical device or IVD
ㆍExperience in leadership role in organization more than 10 HC
ㆍExperience in IVD with understaing of ISO 13485-2016, EU 2017/746(IVDR) and other rapid diagnostic device related international requirement
ㆍExcellent communication skill in English (in technical writing and conversation)
ㆍExceptional communication skills and ability to facilitate cross-functional cooperation
ㆍPreferred  employment in global, international IVD, pharmaceutical firms(>5 years)
 
Experience/Background
Experience    Experience Details
Minimum 15 years    

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

IDEM ARDx Infectious Disease Emerging Markets

        

LOCATION:

Korea > Yongin-si : 65 Borahagal-ro

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 10 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

     

     

     

     

JOB DESCRIPTION:

MAIN RESPONSIBILITIES

• Lead QC organization with 20~30 associates to ensure product quality control is done according to the standard.
• Review & approval of QC result of Biologics, Semi-finished goods & final products of rapid test, ELISA assay and Urine analysis
• Review and approve Verification & Validation of Incoming Materials
• Review the validation and verification test for process and stability testing
• QC standard material (Panel) management
• Manage of Inspection/Audit and CAPA review and approval
• Transfer test method technology
• Review & approval 
• Review and manage of QC Budget

QUALIFICATIONS

Education

Over bachelor degree in relevant major (Knowledge on diagnosis mechanism (Biological, Immunization)

Experience/Background

• Leadership experience in QC (> 10 years) in bioi ndustry , medical device or IVD
• Experience in leadership role in organization more than 10 HC 
• Exceptional Communication skill in English (in technical writing and conversation)
• Exceptional communication skills and ability to facilitate cross-functional cooperation
• Knowledge on GMP & ISO / Regulatory guidelines
• Compressive knowledge Validation, Verification, Stability, Risk assessment, CAPA and change control process based on ISO 13485:2016
• Global inspection experiences

Preferred whom with

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

IDEM ARDx Infectious Disease Emerging Markets

        

LOCATION:

Korea > Yongin-si : 65 Borahagal-ro

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 10 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable