Quality Assurance Engineer Director

Description:

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.

• Job Type: Full-Time
• Location: Hauppauge, NY
• Level: Director
• Works Hours: Monday – Friday, 8:00AM – 4:00PM EST
• Pay Range: $105,000 - $125,000 per year, depending on experience and level
• Start Date: ASAP

What makes this role exciting

• This role sits at the intersection of quality, leadership, compliance and impact
• 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

Requirements:

Responsibilities: Include, but are not limited to:

• 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.