Position Details
About this role
This role is responsible for leading quality operations work including compliance, validation, investigations, and corrective action projects. The position focuses on NCR (Nonconformance Report) and CAPA leadership, regulatory/quality risk assessments, root cause investigations, and meeting effectiveness check metrics and timelines.
Key Responsibilities
- Lead NCR's and CAPA's and related integration/remediation projects within timeline
- Conduct regulatory and quality risk assessments
- Perform root cause investigations for multi-group projects
- Manage effectiveness checks and meet metric requirements
- Lead value stream monthly reviews of metrics and project status
Technical Overview
The technical environment is Quality Operations within a regulated manufacturing context, emphasizing quality systems execution such as validation, NCR/CAPA management, root cause analysis, and effectiveness checking. Work includes value stream metric reviews, remediation/integration project management, and training/ onboarding quality team members.
Ideal Candidate
The ideal candidate is a senior quality professional with experience leading compliance, validation, and investigation projects within Quality Operations. They have hands-on expertise with NCR (Nonconformance Report), CAPA (corrective / preventative action), root cause investigations, and effectiveness checks to meet regulatory and quality timelines and metrics.
Must-Have Skills
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Must be able to lead NCR's and CAPA's and meet effectiveness check metrics, Must have demonstrated experience with root cause investigations and regulatory/quality risk assessments
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