Manager, Quality Systems

Empower Pharmacy•Houston, TX

5d•Onsite

About The Position

Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide. As the nation’s most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility, we’re redefining what’s possible in personalized medicine and pharmaceutical manufacturing. We’re proud to be recognized as one of Houston’s fastest-growing private companies and ranked #116 in Healthcare & Medical on the Inc. 5000 List for 2025. Our strength is built on four core values: People, Quality, Service, and Innovation. Guided by these principles, we’ve created a uniquely integrated healthcare platform powered by advanced technology, operational excellence, and a relentless commitment to patient care. From manufacturing and quality control to distribution and customer experience, our teams work together to raise industry standards, expand access to critical medications, and improve outcomes for patients and providers across the country. At Empower, joining our team means more than starting a new role. It means becoming part of a mission-driven organization that’s transforming healthcare at scale. We invest deeply in our people, encourage bold thinking, and create opportunities for growth, leadership, and innovation at every level. Your ideas matter here, your development is supported, and the work you do has a direct impact on the lives of millions. If you thrive in a fast-moving, purpose-driven environment where innovation, collaboration, and ambition come together, Empower Pharmacy is the place for you. Let’s transform healthcare together. POSITION SUMMARY Leads and scales enterprise quality systems and owns the end-to-end training function for Current Good Manufacturing Practices (cGMP)-regulated 503A/503B manufacturing ensuring compliant operations while accelerating business performance across Empower’s hyper-growth platform. Accountable for the strategy, execution, and continuous improvement of Quality Management Systems (QMS) and Good Manufacturing Practices (GMP) training programs, governing Corrective and Preventive Actions (CAPA), audits, risk frameworks, and workforce competency at scale. Leverages AI as a force multiplier to enhance decision-making, signal detection, training effectiveness, and quality outcomes. Operates with P80–P90 talent expectations, combining strategic leadership with rigorous execution to navigate regulatory complexity, mitigate risk, and address inspection observations. Drives cross-functional alignment, inspection readiness, and data-driven governance, ensuring safe, effective products and sustained regulatory confidence. Builds high-performing teams while establishing standards, metrics, digital controls, and role-based training frameworks that elevate process capability, reduce risk, and close compliance gaps. Partners with manufacturing, engineering, and supply chain to embed quality by design and ensure workforce readiness, enabling scalable growth and consistent inspection success.

Requirements

Deep expertise in QMS, GMP regulations, and regulatory frameworks, with demonstrated leadership of training functions in cGMP environments.
Proven ability to build and scale training programs that withstand FDA scrutiny and drive operational performance.
Strong understanding of human performance, training effectiveness, and compliance risk related to workforce capability.
Advanced problem-solving capabilities, including root cause analysis, risk management, and process optimization, with a focus on leveraging technology to improve speed, accuracy, and scalability.
Experience leveraging digital systems (e.g., LMS) and AI tools to enhance quality systems and training outcomes.
Minimum of 7 years of experience in quality systems management within a pharmaceutical or healthcare manufacturing environment, with proven expertise in GMP compliance, regulatory audits, and process improvements.
Requires a Bachelor’s degree in pharmaceutical sciences, engineering, life sciences, or a related field; Master’s degree in quality management, regulatory affairs, or a related discipline is preferred.
Strong leadership, problem-solving, and strategic planning skills, with the ability to collaborate cross-functionally, communicate effectively at all organizational levels, and foster a culture of continuous improvement.
Comprehensive knowledge of GMP, CAPA, QMS, and regulatory compliance, with proficiency in quality risk management, root cause analysis, and process validation methodologies.

Nice To Haves

Master’s degree in quality management, regulatory affairs, or a related discipline is preferred.
Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), GMP Certification, Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP), and Lean Six Sigma Green Belt or higher.

Responsibilities

Owns the design, implementation, and continuous evolution of QMS and cGMP training systems, ensuring alignment with GMP, FDA, and USP standards while scaling for growth. Integrates AI-enabled monitoring, workflow automation, and predictive analytics to improve system performance, accelerate cycle times, and proactively identify compliance risks across operations.
Drives standardization and optimization of quality processes including CAPA, deviations, change control, documentation practices, and training effectiveness. Leverages AI to detect trends, automate root cause insights, and enhance investigation quality, ensuring robust, repeatable processes that improve compliance, reduce variability, and support inspection readiness.
Establishes governance frameworks, metrics, and review cadences that ensure transparency, accountability, and continuous improvement. Utilizes AI-driven dashboards and advanced analytics to elevate decision-making, strengthen executive visibility, and ensure quality systems scale effectively with increasing operational complexity.
Leads end-to-end inspection readiness strategy, ensuring continuous compliance with regulatory expectations in a dynamic 503A/503B environment. Applies AI tools to simulate inspections, identify gaps, and prioritize remediation activities, enabling confident regulatory engagement and sustained audit performance.
Implements proactive risk management frameworks that identify, assess, and mitigate quality risks across manufacturing and quality systems. Uses AI-enhanced risk modeling and signal detection to anticipate emerging issues, reduce compliance exposure, and strengthen product quality outcomes.
Oversees internal and external audits, ensuring both quality systems and training programs withstand regulatory scrutiny. Drives timely, effective remediation of findings, particularly those related to training gaps, procedural adherence, and operator qualification.
Partners with manufacturing, engineering, and supply chain to embed quality into operational workflows. Leverages AI to connect data streams across functions, enabling real-time insights, faster issue resolution, and improved alignment between quality objectives and production goals.
Ensures robust validation practices across equipment, processes, and systems, including IQ, OQ, PQ, and process validation. Applies AI to enhance validation data analysis, improve protocol efficiency, and ensure scalable, compliant validation strategies.
Leads cross-functional change control processes, ensuring changes are evaluated, implemented, and documented effectively. Uses AI to assess impact, predict downstream risks, and streamline approvals, enabling faster, safer organizational change.
Builds and develops high-performing quality teams aligned to P80–P90 expectations, fostering strategic thinking, execution rigor, and continuous learning. Integrates AI tools into workflows to enhance productivity, upskill talent, and elevate team effectiveness.
Designs and delivers comprehensive training programs on GMP, quality systems, and documentation practices. Leverages AI-enabled learning platforms to personalize training, track competency, and ensure consistent knowledge application across teams.
Champions a culture of quality, accountability, and continuous improvement across the organization. Uses AI-driven insights and performance metrics to reinforce behaviors, recognize excellence, and sustain a high-performance, compliance-focused environment.