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 . 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. 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