Manager, Quality Systems

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.

Quality Systems Leadership

• Systems Ownership: 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.

• Process Excellence: 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.

• Governance Model: 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.

Regulatory Compliance And Risk Management

• Inspection Readiness: 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.

• Risk Mitigation: 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.

• Audit Leadership: 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.

Cross-Functional Integration

• Operational Alignment: 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.

• Validation Oversight: 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.

• Change Enablement: 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.

Team Leadership And Capability Building

• Talent Development: 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.

• Training Strategy: 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.

• Culture Building: 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.

• 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.

Key Competencies

• Customer Focus: Builds trust through customer-centric solutions 

• Strategic AI: Guides responsible AI adoption and adaptation 

• Optimizes Work Processes: Drives efficiency with continuous improvement 

• Collaborates: Partners effectively to achieve shared goals 

• Resourcefulness: Secures and deploys resources efficiently 

• Manages Complexity: Simplifies and solves complex challenges 

• Ensures Accountability: Delivers on commitments with integrity 

• Situational Adaptability: Adjusts approach to shifting conditions 

• Communicates Effectively: Tailors messages to diverse audiences 

Values

• People: Empowering people defines who we are 

• Quality: Excellence in every product, every time 

• Service: Serving others is our highest purpose 

• Innovation: Advancing care through technology and discovery 

• 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.
• Preferred certifications include 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.

Employee Benefits, Health and Wellness:

We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. 

Learn more: https://careers.empowerpharmacy.com/benefits/ 

Physical Requirements

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. Employees are regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.