Senior Manager, Quality Operations

POSITION SUMMARY

Senior Manager, Quality Operations drives operational quality execution, compliance performance, and scalable quality delivery across Empower’s expanding 503B operations. This role owns quality operations oversight, deviation management, batch release, CAPA execution, and cross‑functional quality alignment supporting patient safety, manufacturing continuity, and sustainable business growth. Leveraging AI‑enabled quality analytics, workflow automation, predictive monitoring, and digital compliance platforms as force multipliers, the position accelerates decision‑making, strengthens operational visibility, improves quality consistency, and enhances risk mitigation across regulated environments.

• Operational Oversight – Leads daily quality operations activities supporting compliant manufacturing execution, operational continuity, batch release, and scalable business growth across Empower’s 503B environment. Utilizes AI‑enabled quality analytics, workflow automation, and operational dashboards to improve decision‑making speed, strengthen compliance visibility, accelerate issue resolution, and reinforce disciplined execution supporting enterprise quality objectives and patient safety requirements.
• Deviation Management – Oversees deviation investigations, nonconformance management, CAPA execution, and escalation activities ensuring timely resolution and sustainable corrective actions. Applies AI‑powered trend analysis, predictive monitoring, and digital quality systems to strengthen root cause identification, improve risk mitigation effectiveness, reduce recurrence potential, and support operational consistency across regulated manufacturing and healthcare operations.
• Inspection Readiness – Supports inspection readiness activities, audit preparation, and compliance oversight supporting successful regulatory inspections and internal assessments. Leverages AI‑assisted compliance tools, digital workflow platforms, and reporting dashboards to improve documentation visibility, strengthen audit preparedness, accelerate remediation activities, and maintain operational readiness across rapidly expanding manufacturing operations.

• Compliance Execution – Ensures alignment with FDA regulations, cGMP standards, USP requirements, and internal quality systems supporting enterprise compliance and operational integrity. Utilizes AI‑enabled compliance analytics, workflow automation, and digital governance technologies to improve oversight quality, strengthen execution consistency, reduce operational risk, and support sustainable compliance performance across complex regulated environments.
• Risk Mitigation – Identifies operational vulnerabilities, quality risks, and compliance gaps impacting patient safety, manufacturing continuity, or inspection readiness. Applies AI‑powered predictive analytics, trend monitoring, and operational intelligence tools to strengthen proactive risk prevention, improve escalation responsiveness, accelerate mitigation planning, and support resilient quality execution across enterprise operations.
• Governance Alignment – Partners with Manufacturing, Regulatory, Supply Chain, Validation, and Quality teams to align operational priorities, strengthen governance frameworks, and improve quality execution consistency. Leverages AI‑enabled collaboration tools, reporting technologies, and operational analytics to accelerate decision‑making, reinforce accountability, improve communication effectiveness, and support scalable compliance governance across evolving operational environments.

• Process Optimization – Leads quality process improvement initiatives enhancing operational efficiency, compliance execution, workflow scalability, and organizational consistency across manufacturing operations. Utilizes AI‑powered analytics, automation technologies, and continuous improvement methodologies to eliminate inefficiencies, strengthen process standardization, improve quality outcomes, and support scalable operational growth within regulated healthcare and pharmaceutical environments.
• Performance Management –…