Director, Quality Assurance

Responsibilities

• Quality Leadership
• Leads Quality Assurance operations ensuring compliance with FDA regulations, cGMP requirements, and industry standards.
• Utilizes AI-enabled analytics and monitoring tools to strengthen compliance visibility, improve execution consistency, reduce regulatory risk, and support scalable quality performance while maintaining product integrity and patient safety across regulated manufacturing environments.
• Directs inspection readiness, including preparation, execution, and response management for audits.
• Leverages AI-powered compliance tools and reporting platforms to improve readiness visibility, accelerate remediation, strengthen documentation accuracy, and ensure successful inspection outcomes while reinforcing enterprise quality systems.
• Oversees internal audit programs that assess quality systems and compliance.
• Applies AI-assisted analytics to identify gaps, improve processes, accelerate issue resolution, and reinforce continuous improvement initiatives supporting enterprise compliance and operational performance.
• Directs supplier quality programs, including qualification, monitoring, and auditing across vendors.
• Utilizes AI-enabled analytics and dashboards to improve supplier oversight, mitigate risks, and ensure consistent product quality across the supply chain.
• Provides leadership for validation activities including equipment, process, and system validation.
• Leverages AI-powered analytics to improve process robustness, strengthen compliance, reduce variability, and support reliable manufacturing performance.
• Oversees quality systems, including training, document control, and records management.
• Applies AI-enabled automation and digital tools to improve efficiency, strengthen data integrity, and support scalable quality operations.
• Ensures adherence to FDA regulations, USP standards, and cGMP practices.
• Utilizes AI-enabled monitoring and analytics to strengthen compliance execution, improve oversight, and reduce regulatory risk.
• Oversees deviations, investigations, CAPAs, and change controls.
• Applies AI-powered analytics to improve root cause identification, strengthen corrective actions, and enhance quality system effectiveness.
• Leads risk management efforts to identify compliance vulnerabilities and operational gaps.
• Leverages predictive analytics to improve mitigation planning and support resilient quality operations.
• Partners cross-functionally to integrate quality requirements into business processes.
• Utilizes AI-enabled collaboration tools to improve alignment and support compliant execution.
• Establishes KPIs to monitor quality performance and compliance trends.
• Applies AI-powered dashboards to improve visibility and support data-driven decisions.
• Drives initiatives improving quality systems and operational efficiency.
• Leverages AI analytics and structured methodologies to strengthen outcomes and support growth.
• Builds high-performing quality teams that foster accountability and continuous improvement.
• Utilizes AI-enabled workforce analytics to improve engagement and capability.
• Aligns quality priorities with executive and cross-functional teams.
• Leverages AI-enabled tools to improve communication and decision-making.
• Provides updates on quality performance and compliance risks.
• Uses AI-powered reporting tools to improve visibility and support business planning.

Requirements

• Bachelor’s degree in scientific or technical discipline required.
• Minimum 10 years of pharmaceutical quality experience, including regulatory inspection leadership.
• Experience overseeing quality systems, supplier quality, validation, and compliance programs.
• Experience implementing digital quality systems and process improvements preferred.
• Proven ability to lead teams and drive measurable quality and compliance outcomes.
• Lean Six Sigma Green Belt, Certified Pharmaceutical Industry Professional (CPIP), Professional Engineer (PE), or Certified Quality Engineer (CQE) certification preferred.