Manager, Quality Systems

Location: East Windsor, New Jersey 08520, United States

Posted: April 25, 2025

Job Type: Full Time

Req# 4013

Quality

Company Overview

Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets.

What sets us apart is our relentless focus on four core values: People, Quality, Service and Innovation. Our dedicated team of professionals collaboratively works to break new ground in the fields of manufacturing, distribution and quality control, providing a uniquely integrated approach to healthcare. Leveraging our vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and a commitment to excellence, we are constantly pushing the boundaries of what is possible in medication accessibility and affordability.

You're not just starting a job; you're joining a mission. We believe in empowering our team to innovate, grow, and drive real change in the healthcare industry. If you're a forward-thinker who thrives in a fast-paced, transformative environment, Empower is the place for you. Here, you’ll be encouraged to share your ideas, expand your skill set, and contribute to projects that genuinely make a difference. We prioritize the well-being of our team members, and we offer a supportive and engaging workplace where your contributions are not just recognized but celebrated.

Let’s revolutionize healthcare, together. Join us and be a part of something extraordinary.

Position Summary

Quality is the foundation of everything we do, ensuring patients receive safe, effective medications. As the Manager of Quality Systems, you will drive compliance with Good Manufacturing Practices, strengthen quality processes, and foster continuous improvement. At Empower Pharmacy, this is your opportunity to lead with impact, innovate with purpose, and expand access to quality, affordable medication.

Duties And Responsibilities

• Manages the development and implementation of quality management systems to ensure compliance with regulatory priorities, Good Manufacturing Practices (GMP), and industry standards while overseeing Quality Systems improvements to maintain adherence to United States Food and Drug Administration and United States Pharmacopeia standards.
• Leads audits, Corrective and Preventive Actions (CAPA), investigations, Quality Management Reviews (QMR), and Risk Management to ensure compliance, continuous improvement, and data-informed quality initiatives.
• Collaborates with manufacturing and production teams to maintain Standard Operating Procedures, ensuring GMP compliance, managing change controls, compiling quality metrics for QMR, and supporting equipment validation, including Installation Qualification, Operational Qualification, Performance Qualification, Process Validation, and commissioning and decommissioning.
• Manages investigations of deviations, non-conformances, and customer complaints by conducting root cause analysis, implementing CAPA, ensuring preventive measures, and supporting inspections, audits, and quality meetings to maintain product integrity.
• Develops and delivers training on documentation practices, GMP, and quality topics to ensure regulatory compliance while fostering a culture of quality excellence and strengthening staff expertise in quality systems.
  
  

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. The employee is 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.

Knowledge And Skills

• 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 Good Manufacturing Practices, Corrective and Preventive Actions, Quality Management Systems, and regulatory compliance, with proficiency in quality risk management, root cause analysis, and process validation methodologies.
  
  

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
  
  

Values

• People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
• Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
• Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.
• Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.
  
  

Experience and Qualifications

• 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.
• Preferred certifications include Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Good Manufacturing Practices Certification, Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP), and Lean Six Sigma Green Belt or higher.
• Demonstrated experience leveraging AI in daily work to drive efficiency, solve problems, and enhance decision-making—adept at integrating AI-powered solutions into all workflows.
  
  

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/