Quality Technical Manager
Description
JOB DESCRIPTION
Job Title: | Quality Technical Manager |
Department / Cost Center: | External Quality / 687 |
Reports to (Job Title): | Director, Drug Product Market Release |
Job Code: |
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Location: | Japan office |
Date Prepared: | 17JAN2024 |
SUMMARY DESCRIPTIONState the overall function or purpose of the job.
This position reports to the Director of Drug Product Market Release within the External Quality organization and will maintain responsibility, oversight, and management of quality-related activities for drug product releases to Japan and APAC region as required.
As part of the External Quality team, the responsibilities consist of maintaining the compliance profile and quality mindset including planning, implementation, project management and management of applicable Quality Systems and oversight of partners. The manager will work closely with peers in a team-matrix environment to have proper oversight of all the partner(s).
The Quality Manager is responsible for the support of Quality Assurance (QA) and Quality Control (QC) activities specifically to Japan as required by GQP ordinances and the APAC region. The Quality Manager interacts with partners that act as Marketing Authorization Holders of BioMarin products to accomplish Quality Technical Agreement (QTA) activities and provide QA support to Supply chain Management (SCM) related activities.
This position will be based in Tokyo, Japan and will require travel.
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RESPONSIBILITIESList the major responsibilities of the job. |
Specifically to Japan, the Quality Manager is responsible for all QA duties required at the Japan entity in accordance with Good Quality Practice (GQP) and Good Manufacturing Practice (GMP) for QC, secondary packaging and visual inspection.
A) Perform the duties of the Quality Manager to ensure company products, procedures and policies are in compliance with Japanese regulations, Good Quality Practices (GQP), Good Manufacturing Practices (GMP) and BioMarin’s Global procedures. These duties include, but are not limited to:
B) Other duties include:
SKILLS and KNOWLEDGE
The ideal candidate will have the following skills:
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SCOPEQuantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc. |
This position is needed to assure continuity business of Marketing Authorization Holders of Drug Product in the region that have responsibilities to follow local/APAC requirements, regardless of the responsibilities of Distribution partner.
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EDUCATIONState both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc. |
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EXPERIENCEState both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job. |
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WORK ENVIRONMENT / PHYSICAL DEMANDSDescribe the work environment characteristics that an employee encounters while performing the essential functions of the job. |
None
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EQUIPMENTDescribe any equipment required to perform the job. |
Standard Company assigned equipment
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