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
• 4:00

PM EST Pay Range:

$125,000

• $150,000 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.