Supervisor, Quality Operations

Empower Pharmacy•Houston, TX

50d•Onsite

About The Position

As Supervisor, Quality Operations, you lead frontline quality execution across aseptic manufacturing, ensuring compliant, timely, and risk-based decisions that directly protect product quality, patient safety, regulatory readiness, and business performance. You own daily oversight of batch record review, deviation management, investigations, CAPA effectiveness, lot disposition, and quality system execution across a multi-shift operation. Leveraging AI as a force multiplier, you enhance review speed, decision quality, trend detection, knowledge access, and operational scalability while maintaining human accountability for regulated outcomes. Operating within Empower’s hyper-growth 503A and 503B environment, you drive disciplined execution, continuous improvement, and inspection readiness. Success requires P80–P90 talent capable of strategic thinking, execution rigor, learning agility, cross-functional influence, and consistent delivery in complex, fast-evolving, highly regulated settings while developing teams, strengthening collaboration, and accelerating measurable results at scale.

Requirements

Advanced knowledge of cGMP regulations, aseptic manufacturing, quality systems, investigations, CAPA management, batch record review, and risk-based decision-making within highly regulated production environments.
Proficiency with quality management systems, electronic documentation platforms, data analytics tools, and AI-enabled technologies that improve compliance monitoring, workflow efficiency, and operational visibility.
Strong leadership, coaching, communication, and stakeholder management capabilities with the ability to influence outcomes, resolve complex issues, and drive accountability across cross-functional teams.
Demonstrated ability to analyze data, identify trends, manage competing priorities, and execute continuous improvement initiatives while maintaining quality, compliance, and business performance objectives.
Minimum of 3 years of experience in pharmaceutical quality, including 2 years in a supervisory role.
Bachelor of Science degree in a technical or scientific discipline.
Possesses knowledge of pharmaceutical manufacturing, United States Pharmacopeia <797>, cGMP, Food and Drug Administration regulations (21 Code of Federal Regulations Parts 210, 211), and International Council for Harmonisation regulations, with proficiency in computer software, particularly SharePoint.

Nice To Haves

American Society for Quality (ASQ) Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or an equivalent certification preferred.

Responsibilities

Lead daily review and disposition activities across manufacturing operations, ensuring batch documentation accuracy, data integrity, and compliance with established quality standards. Utilize AI-enabled review tools to accelerate record assessment, identify anomalies, prioritize risk, and improve decision consistency while maintaining accountability for final quality determinations, cycle-time performance, and regulatory readiness.
Direct investigations related to deviations, excursions, nonconformances, and quality events, ensuring timely containment, root cause identification, and effective resolution. Leverage AI-supported analytics to uncover trends, strengthen investigative rigor, improve documentation quality, and accelerate issue resolution while ensuring actions align with regulatory expectations, operational priorities, and patient safety requirements.
Oversee lot disposition activities and release workflows to ensure products meet quality requirements before distribution. Apply data-driven and AI-assisted insights to evaluate risk, streamline review processes, and improve release efficiency while maintaining compliance, protecting product quality, and supporting reliable supply within a rapidly scaling manufacturing environment.
Supervise corrective and preventive action processes from initiation through effectiveness verification, ensuring sustainable solutions address underlying causes. Use AI-driven pattern recognition and trend analysis to identify recurring issues, strengthen preventive strategies, improve execution quality, and support continuous improvement initiatives that enhance operational performance and compliance outcomes.
Review and approve quality-related changes, ensuring appropriate risk assessment, stakeholder alignment, and regulatory compliance. Leverage AI-enhanced knowledge management tools to evaluate historical outcomes, identify potential impacts, and support informed decision-making while maintaining control, consistency, and effectiveness across quality systems and manufacturing processes.
Maintain oversight of cGMP adherence, procedural compliance, and quality system effectiveness across assigned operations. Utilize AI-enabled monitoring capabilities to identify emerging risks, prioritize corrective actions, and improve visibility into compliance performance while supporting inspection readiness, audit preparedness, and sustained operational excellence.
Lead, coach, and develop quality professionals through performance management, training, and cross-functional collaboration. Foster a high-accountability culture where AI tools enhance productivity, learning, and decision support while employees strengthen technical expertise, problem-solving capabilities, and ownership of quality outcomes in a highly regulated environment.
Build a high-performing team aligned to Empower’s P80–P90 talent expectations by reinforcing strategic thinking, execution discipline, and learning agility. Create opportunities for growth, knowledge sharing, and capability development while leveraging technology and AI to increase effectiveness, scalability, and organizational impact.
Partner closely with Manufacturing, Validation, Engineering, Laboratory, and Regulatory teams to resolve issues, improve processes, and drive business objectives. Utilize AI-supported collaboration and data-sharing tools to accelerate decisions, improve communication quality, and strengthen alignment across functions while maintaining quality-first outcomes.
Identify opportunities to improve workflows, eliminate inefficiencies, and strengthen quality performance across operations. Apply AI-enabled analytics, automation, and process intelligence to accelerate cycle times, improve consistency, reduce manual effort, and enhance overall effectiveness while preserving compliance and quality standards.
Drive proactive risk identification, assessment, and mitigation activities across quality operations. Utilize predictive analytics and AI-assisted trend monitoring to detect emerging concerns, prioritize actions, and support informed decision-making that reduces operational risk, protects product quality, and strengthens regulatory confidence.
Ensure continuous preparedness for internal audits, customer assessments, and regulatory inspections through disciplined execution and documentation practices. Leverage AI-powered knowledge retrieval, compliance monitoring, and trend analysis tools to strengthen readiness, improve response quality, and support successful inspection outcomes within a hyper-growth environment.