Quality Assurance Engineer Director
About The Position
We’re looking for a Quality Assurance Engineer Director who is a key member of the Quality Assurance unit within a pharmaceutical manufacturing environment. This role is responsible for technical leadership and enhancement of quality system activities including but not limited to, quality event investigations (deviations, complaints, non-conformances, and OOS), protocol writing (reworks and reprocessing), Annual Product Reviews, Stability Protocol and Report, Risk Assessments and CAPAs. The Quality Assurance Engineer Director oversees a team that applies engineering, analytical, and risk-based thinking to identify systemic issues, improve process robustness, and strengthen inspection readiness.
Responsibilities
- Leads a team that author complex quality event investigations (deviations, complaints, non-conformances, and OOS), protocols (reworks and reprocessing), risk assessments and CAPAs.
- Apply structured problem-solving methodologies (e.g., lean and six-sigma, DMAIC, root cause analysis, FMEA, fishbone, 5-Why) to drive high-quality, defensible conclusions.
- Ensure all documentation meets cGMP, FDA, EMA, and internal quality standards, with a focus on clarity, logic, and inspection-ready narratives.
- Review and challenge investigation content prepared by cross-functional teams to elevate overall quality and consistency.
- Drive the development of robust, risk-based CAPAs that address true root causes rather than symptoms.
- Assess CAPA effectiveness and sustainability; identify trends and opportunities for system-level improvements.
- Coach and mentor Quality Engineer and related QA staff by modeling industry standard investigation practices.
- Analyze trends across quality vents to identify systemic risks, recurring failure modes, and opportunities for process improvement.
- Support continuous improvement initiatives by translating quality data into actionable insights.
- Contribute to the design or enhancement of quality processes, templates, and tools to improve investigation quality and efficiency.
- Serve as a thought partner to operations and technical teams during issue resolution and change management activities.
- Act as a trusted QA partner to external customer and internal departments including Manufacturing, Packaging, Engineering, Technical Operations, Accounts Management, and Supply Chain.
- Provide risk-based quality input to support sound business decisions while maintaining regulatory compliance.
- Support inspection readiness activities, including responses to regulatory questions related to investigations and CAPAs.
- Complete internal audits and support external audits of CPC operations.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
Number of Employees
501-1,000 employees
