Tài liệu Site QA Manager Role Description docx

Site QA Mgr Job Descr.doc page 1 of 1 10/15/09
Site QA Manager Role Description

Site QA Manager
QA-
Tasks
• Define and lead Quality culture at the site (including getting the Plant Manager enrolled in the quality
culture)
• Develop & gain support for Quality Action Plans at the site to meet the GBU Quality goals. (internal and
external measures)
• Manage and close gaps to the GBU and site
Quality goals
• Enroll Site line management into site Quality goals and action plans
• Build capability in all quality-related site personnel to accomplish Quality goals (including QA personnel
and those doing quality-related DMS work)
• Own the RM and FP release systems - QA-run & quality-related DMS
• Identify, summarize and drive resolution of
issues with supplier material Quality, and feed back to
Purchasing and the GBU QA
• Own site’s Technical Standard and SOP systems
• Execution of QA system in Product launch modle.
• Staff and manage Micro Lab (PS)
• Staff and manage Analytical Lab (PS)
• Manage 19 QAKE systems
• Own Key Element 16 - SIP
• Own the IWS Q-Pillar
• Act as technical resource in quality sub-systems such as micro, statistics, design standards, etc..
• Site Leadership Team member
• Contract Manufacturing (KE#19) Quality Leader
• Regulatory/Legal contact for Quality issues.

SKILLS
Top SAWs (list 2-
3 most important
SAWs for this
level)
• Leadership
• Innovation
• Capacity
• Risk Taking

Mastery (QA
technical
competencies
required)
• Basic QA Organization
• Intermediate QA Theory & Applications
• Intermediate (or Advanced) Product/Package/Process (dependent on size of site/number of products)

• Intermediate Leadership in QA
• Intermediate Quality Tools
• Intermediate Regulations & Policies
• Intermediate QC Lab Management
• Advanced Quality Measures & Pillar

• Advanced System Development

PERFORMANCE
STANDARDS

Top Performer

For both the
business and
organization
capability describe
what differentiates
a top performer
• Creates and applies excellent ideas which lead to excellent business results
• Performs in a very independent manner on complex projects
• Well respected inside and outside of the department/organization/ company
• Seeks to reapply systems and approaches that work
• Manages risk successfully and independently to meet business and quality expectations
Meets
Expectations
• Obtains breakthrough results in some areas
• Always works within current systems effectively, and initiates and achieves improvements in systems
inside and outside own work area
MINIMUM ENTRY
REQUIREMENTS

Education and any
relevant Quality
Related
Experience
Multiple assignments in R&D or PS, in various roles (QA or plant systems)
Plus any local requirements that may apply



Deleted: Set
Deleted: goals

Deleted: <#>Build capability in all
quality-related site personnel to
accomplish Quality goals (including
QA personnel and those doing
quality-related DMS work)¶
Deleted: Resolve
Deleted: <#>Define and lead Quality
culture at the site¶
Deleted: (or Advanced)
Deleted: QA
Deleted: Advanced QAKEs
Deleted: Advanced Capability
Building
Deleted: Advanced Risk
ManagemenExpert Q Pillar