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About the Role

This role provides technical leadership and enhances quality system activities within a pharmaceutical manufacturing environment. The Quality Assurance Engineer Director oversees a team focused on improving process robustness, strengthening inspection readiness, and applying engineering, analytical, and risk-based thinking to identify systemic issues.

Responsibilities

• Leads a team that authors complex quality event investigations (deviations, complaints, non-conformances, and OOS), protocols (reworks and reprocessing), risk assessments, and CAPAs.
• Applies structured problem-solving methodologies (e.g., lean and six-sigma, DMAIC, root cause analysis, FMEA, fishbone, 5-Why) to drive high-quality, defensible conclusions.
• Ensures all documentation meets cGMP, FDA, EMA, and internal quality standards, with a focus on clarity, logic, and inspection-ready narratives.
• Reviews and challenges investigation content prepared by cross-functional teams to elevate overall quality and consistency.
• Drives the development of robust, risk-based CAPAs that address true root causes rather than symptoms.
• Assesses CAPA effectiveness and sustainability; identifies trends and opportunities for system-level improvements.
• Coaches and mentors Quality Engineer and related QA staff by modeling industry standard investigation practices.
• Analyzes trends across quality events to identify systemic risks, recurring failure modes, and opportunities for process improvement.
• Supports continuous improvement initiatives by translating quality data into actionable insights.
• Contributes to the design or enhancement of quality processes, templates, and tools to improve investigation quality and efficiency.
• Serves as a thought partner to operations and technical teams during issue resolution and change management activities.
• Acts as a trusted QA partner to external customers and internal departments including Manufacturing, Packaging, Engineering, Technical Operations, Accounts Management, and Supply Chain.
• Provides risk-based quality input to support sound business decisions while maintaining regulatory compliance.
• Supports inspection readiness activities, including responses to regulatory questions related to investigations and CAPAs.
• Completes internal audits and supports external audits of CPC operations.

Requirements

• Technical leadership and enhancement of quality system activities including quality event investigations, protocol writing, Annual Product Reviews, Stability Protocol and Report, Risk Assessments and CAPAs.
• Oversees a team that applies engineering, analytical, and risk-based thinking to identify systemic issues, improve process robustness, and strengthen inspection readiness.
• Define quality engineering strategies and lead cross-functional teams.
• Review advanced analytics and help modernize manufacturing systems.
• Serve as the subject matter expert on data aggregation and analysis for the company’s annual product review, continuous process verification and stability programs.

Skills

• Quality Assurance
• Pharmaceutical Manufacturing
• Quality Systems
• Technical Leadership
• Engineering
• Analytical Skills
• Risk-Based Thinking
• Problem-Solving Methodologies
• cGMP
• FDA
• EMA
• CAPA
• Root Cause Analysis
• FMEA
• Fishbone
• 5-Why
• Lean
• Six-Sigma
• DMAIC
• Data Aggregation
• Data Analysis
• Continuous Process Verification
• Stability Programs
• Change Management
• Auditing

Location

• Hauppauge, NY

Work Type

• Full-Time

Experience Level

• Director

Salary/Compensations

• $125,000 - $150,000 per year