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Manager, Quality Assurance

Location: East Windsor, New Jersey 08520, United States
Posted: April 1, 2025
Job Type: Full Time
Req# 3499
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

As a Manager, Quality Assurance, you will be at the forefront of ensuring compliance, quality, and regulatory excellence across multiple locations within your designated region. You will lead quality initiatives, drive improvements, and enforce compliance with current Good Manufacturing Practices (cGMP), United States Pharmacopeia (USP) standards, and Food and Drug Administration (FDA) regulations. Your ability to collaborate with cross-functional teams, analyze quality data, and proactively address regulatory risks will play a crucial role in maintaining Empower Pharmacy’s reputation for excellence.

Duties and Responsibilities
  • Leads the regional quality oversight program, ensuring full compliance with cGMP, the Code of Federal Regulations, and USP standards while maintaining consistency and excellence across all locations.
  • Develops and implements comprehensive internal audit strategies, conducting thorough regional audits and collaborating with site teams to address findings, drive corrective actions, and strengthen overall compliance.
  • Oversees the internal audit program and provides critical support during regulatory inspections, ensuring all sites maintain continuous inspection readiness and adhere to FDA and state pharmacy board requirements.
  • Partners with cross-functional teams to enhance quality processes by proactively managing deviations, investigations, Corrective and Preventive Actions (CAPAs), and change control initiatives to drive operational excellence and regulatory alignment.
  • Leads, mentors, and empowers site-level Quality Assurance teams, fostering a culture of compliance, accountability, and continuous improvement to uphold the highest standards of pharmaceutical manufacturing and patient safety.

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 communicate effectively across all levels of management, drive continuous improvement, and integrate artificial intelligence (AI) to enhance decision-making and operational efficiency.
  • Expertise in cGMP compliance, quality systems management, risk assessments, and regulatory inspection preparedness, with experience leading internal audits, investigations, and CAPAs through root cause analysis and AI-powered solutions.

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 pharmaceutical manufacturing, sterile compounding, or regulated healthcare environments, with at least 3 years in a leadership or quality management role.
  • Requires a Bachelor’s degree in a Scientific or Technical discipline (e.g., Pharmacy, Biology, Chemistry, Engineering) from an accredited institution.
  • Certified Quality Auditor (CQA), Certified Pharmaceutical GMP Professional (CPGP), or equivalent quality/regulatory certification preferred.
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/