Manager, Quality Systems

Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide. As the most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility serving the functional medicine markets, we are 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 lies in four core values—People, Quality, Service, and Innovation. Guided by these principles, we deliver a uniquely integrated approach to healthcare through vertical supply chain integration, advanced technology, and a relentless pursuit of excellence. From manufacturing to distribution to quality control, our teams work collaboratively to push boundaries, improve patient outcomes, and redefine medication accessibility.

At Empower, joining our team means more than starting a new job, it means becoming part of a mission to transform healthcare. We empower our employees to innovate, grow, and make a meaningful impact every day. Here, your ideas are valued, your growth is supported, and your contributions are celebrated.

If you thrive in a fast-paced, transformative environment where innovation meets purpose, Empower Pharmacy is the place for you. Let’s revolutionize healthcare together.

Position Summary:

Leads and scales enterprise quality systems and owns the end-to-end training function for cGMP-regulated 503A/503B manufacturing, ensuring compliant operations while enabling business performance across a high-growth environment. This role is accountable for the strategy, execution, and continuous improvement of Quality Management Systems (QMS) and GMP training programs, including governance of CAPA, audits, risk frameworks, and workforce competency at scale.

The role leverages AI and automation to enhance decision-making, signal detection, training effectiveness, and quality outcomes. Success requires strong strategic leadership and disciplined execution to navigate regulatory complexity, mitigate risk, and maintain inspection readiness while driving cross-functional alignment and scalable quality operations.

Responsibilities: 

Quality Systems Leadership

• Systems Ownership: Design, implement, and continuously improve QMS and cGMP training systems aligned with GMP, FDA, and USP standards.
• Process Excellence: Standardize and optimize quality processes including CAPA, deviations, change control, documentation, and training effectiveness.
• Governance Model: Establish governance frameworks, performance metrics, and review cadences to ensure accountability and continuous improvement.

Regulatory Compliance and Risk Management

• Inspection Readiness: Lead inspection readiness strategy to maintain continuous compliance in a 503A/503B environment.
• Risk Mitigation: Implement proactive risk management frameworks to identify and mitigate quality risks across operations.
• Audit Leadership: Oversee internal and external audits and ensure timely remediation of findings, including training and compliance gaps.

Cross-Functional Integration

• Operational Alignment: Partner with manufacturing, engineering, and supply chain to embed quality into operational workflows.
• Validation Oversight: Ensure robust validation practices across equipment, processes, and systems (IQ, OQ, PQ, and process validation).
• Change Enablement: Lead change control processes to ensure changes are evaluated, implemented, and documented effectively.

Team Leadership and Capability Building

• Talent Development: Build and develop high-performing quality teams with a focus on execution, accountability, and continuous learning.
• Training Strategy: Design and deliver GMP and quality systems training programs to ensure workforce competency and compliance.
• Culture Building: Foster a culture of quality, accountability, and continuous improvement across the organization.

Knowledge and Skills:

• Deep expertise in QMS, GMP regulations, and regulatory frameworks.
• Proven ability to build and scale training programs that withstand regulatory scrutiny.
• Strong understanding of workforce capability, training effectiveness, and compliance risk.
• Advanced problem-solving skills, including root cause analysis, risk management, and process optimization.
• Experience leveraging digital systems such as LMS and automation tools to improve quality outcomes.

Experience and Qualifications: 

• Minimum of 7 years of experience in quality systems management within pharmaceutical or healthcare manufacturing environments.
• Bachelor’s degree in Pharmaceutical Sciences, Engineering, Life Sciences, or a related field required; master’s degree preferred.
• Strong leadership, communication, and cross-functional collaboration skills.
• Comprehensive knowledge of GMP, CAPA, QMS, regulatory compliance, and validation methodologies.
• Preferred certifications include CQA, CQE, GMP Certification, CPGP, and Lean Six Sigma Green Belt or higher.

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

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.