Manager, Quality Assurance - West Chester, OH
1 month ago
Job summary
The Manager Quality Assurance will be accountable for all QA activities and decisions to directly support GMP production operations in a Process Execution Team PET These activities and decisions include change control technology transfer and project support documentation equipment and process validation deviation investigations SOPs regulatory interactions medical device management support This role will evolve to provide leadership daily support supervision of GMP operations The Manager Quality Assurance will develop quality support program technical projects programs to support GMP manufacturing training QA personnel oversee daily activities QA staffResponsibilities
- Develops maintains high level understanding technical production process quality systems utilized within Process Execution Team PET Accountable QA decision-making PET works PET leaders team members deliver PET site objectives Provide direction development performance management Quality professionals supporting PET Accountable QA review approval following GMP documentation direct impact on activities performed by equipment facilities utilized by PET Change Management Change controls Quality Investigations Deviations supplier deviations Support Technical Transfers Validation Plans Protocols reports Standard Operating Procedures Risk Assessments Medical device management Supervise coach assist employee development performance ensure fair equitable workplace Collaborates other managers Quality professionals from other sites ensure consistent application key quality systems across all sites Interfaces Site Support Groups improvement projects capital noncapital impact MET proactively ensure compliance during planning execution closeout phases Work cross-functionally area process teams metrics reviews operational issue/deviation management Ensures MET complies with all Compliance Regulatory requirements providing proper coaching mentoring consultation Ensure batch documentation review product disposition quality issues resolutions executed maintain flow products documents meet objectives Foster strong quality culture maintaining open communications promoting teamwork participation workgroup
Job description
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