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. Success requires strategic thinking, execution rigor, learning agility, and decisive leadership within a hyper-growth organization balancing operational scalability, regulatory expectations, and manufacturing complexity. Talent consistently demonstrates accountability, operational discipline, proactive problem solving, and cross-functional leadership supporting compliance excellence, enterprise trust, inspection readiness, and long-term organizational performance across all operations.

RESPONSIBILITIES

Quality Operations

• 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 And Governance

• 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.

Operational Excellence

• 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: Establishes quality KPIs, operational metrics, and reporting frameworks supporting measurable performance improvement and executive visibility. Applies AI-enabled dashboards, predictive reporting technologies, and operational intelligence tools to improve performance transparency, strengthen accountability, accelerate issue identification, and support enterprise quality optimization initiatives aligned with business growth objectives.
• Operational Readiness: Oversees operational readiness activities supporting manufacturing scalability, product launches, and sustainable quality execution across evolving business operations. Leverages AI-assisted forecasting, compliance tracking, and operational planning tools to improve readiness visibility, strengthen execution consistency, reduce operational disruptions, and support long-term organizational scalability aligned with quality and compliance expectations.

Leadership And Development

• Team Leadership: Leads and develops high-performing quality operations teams while promoting accountability, operational discipline, continuous improvement, and execution excellence. Utilizes AI-enabled workforce analytics, performance insights, and knowledge management platforms to strengthen leadership effectiveness, improve employee engagement, support succession planning, and reinforce Empower’s enterprise quality culture across fast-paced regulated operations.

• Stakeholder Communication: Delivers operational quality updates, compliance insights, remediation strategies, and enterprise risk assessments supporting leadership visibility and business planning activities. Applies AI-powered reporting platforms, predictive analytics, and operational dashboards to improve communication clarity, strengthen strategic decision-making, accelerate alignment, and support sustainable operational and compliance performance across Empower’s enterprise.

• Continuous Learning: Drives adoption of advanced quality technologies, operational best practices, and AI-enabled compliance capabilities supporting scalable operational excellence and enterprise transformation initiatives. Demonstrates learning agility, strategic problem solving, and disciplined execution while reinforcing a culture of innovation, accountability, and continuous improvement supporting Empower’s long-term growth and regulatory leadership objectives.

KNOWLEDGE AND SKILLS

• Deep expertise in quality operations, FDA regulations, cGMP standards, USP requirements, deviation management, CAPA execution, inspection readiness, and compliance governance within highly regulated pharmaceutical or healthcare environments.

• Proven ability leveraging AI-enabled analytics, predictive monitoring, workflow automation, and digital quality systems improving operational visibility, compliance oversight, risk mitigation, and enterprise decision-making effectiveness.

• Strong leadership, communication, and stakeholder management skills with demonstrated success aligning cross-functional teams, resolving operational challenges, and driving measurable quality and compliance outcomes.

• Advanced analytical thinking, operational discipline, and continuous improvement capabilities with experience implementing scalable governance frameworks, quality optimization initiatives, and enterprise operational performance strategies.

EXPERIENCE AND QUALIFICATIONS

• Bachelor’s degree in Quality, Pharmaceutical Sciences, Chemistry, Biology, Healthcare Administration, Operations, or related discipline required; advanced degree preferred.

• Minimum 10 years of progressive quality, compliance, manufacturing, or operational leadership experience supporting pharmaceutical, biotechnology, healthcare, or similarly regulated environments preferred.

• Demonstrated experience leading quality operations, inspection readiness initiatives, deviation management programs, CAPA execution, and enterprise compliance activities strongly preferred.

• Experience implementing AI-enabled quality technologies, digital compliance systems, workflow automation platforms, and predictive analytics tools supporting operational scalability preferred.

• Proven ability to lead high-performing teams, execute strategically, influence cross-functional stakeholders, and drive measurable quality and operational performance outcomes within hyper-growth environments.