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Manager, Quality Assurance
2 months ago
The Manager, Deviations Management, is responsible for leading the Resilience team in the classification, investigation, root cause determination, effective Corrective and Preventive Actions creation and on-time closure of major and critical investigations.
Key Responsibilities- Leads, manages, and builds investigations team
- Ensures team is trained on the appropriate investigational and root cause tools to ensure readiness for GMP operations
- Transfers the deviation management process from our sister site while building out the investigations team
- Administers company policies that directly impact employees
- Completes required administrative tasks (i.e., timecard approvals, time off approvals, expense reports etc.)
- Performs other duties, as assigned
- Manages, leads, develops and mentors team of investigators while overseeing, organizing, and coordinating the tasks of Investigation team
- Ensures on-time closure of investigations while also maintaining high quality investigation standards
- Serves as the primary manufacturing contact for customers regarding investigation management, specific investigations, and investigation status
- Manages and drives continuous improvement by holding investigating team accountable to create effective Corrective and Preventive Actions (CAPA)
- Works cross-functionally with other managers from the Manufacturing Support team to ensure a team of auxiliary investigators are identified, trained, and maintain competency as investigators in order ensure on-time closure while ensure quality investigations
- Maintains resilience and mfg. support compliance metrics and KPIs including on-time CAPA closures and effectiveness checks
- Acts as investigations lead during regulatory inspections and audits
- Fosters an inclusive, people-first culture by creating meaningful development plans with direct reports and conducting 1:1s / skip level 1:1s on a defined cadence
- Completes required administrative tasks (i.e., timecard approvals, time off approvals, expense reports etc.)
- Performs other duties as assigned
- High School diploma or GED with 10 years life sciences, pharmaceuticals or regulated industries OR
- Bachelor's Degree with 6 years life sciences, pharmaceuticals or regulated industries OR
- Master's Degree with 4 years of life sciences, pharmaceuticals or regulated industries
- Prior experience managing, leading, and developing people
- Experience with regulatory inspections, investigations and change management
- Prior knowledge and experience various root cause analysis tools
- 2-3 years of experience leading investigations or an investigations team
- 6-10 years experience in pharmaceutical / biological manufacturing operations
- Previous experience leading others in a pharmaceutical/biological manufacturing facility
- Experience working in a changing, project-driven organization
- Lean certification or similar certifications
