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Director, Quality Control 503B

Location: East Windsor, New Jersey 08520, United States
Posted: March 26, 2025
Job Type: Full Time
Req# 2946
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

The Director of Quality Control is essential to Empower’s mission of providing innovative, affordable medications. This role leads the development of a high-performing laboratory network, ensuring efficient, high-quality testing and regulatory compliance. By optimizing laboratory systems and driving continuous improvement, the Director helps ensure the reliability and quality of our products.

Duties and Responsibilities
  • Develops and oversees a comprehensive laboratory network that integrates internal resources and external partnerships to ensure efficient, high-quality chemical and microbiological testing that meets all operational and regulatory needs.
  • Strategically builds and enhances internal laboratory capabilities while optimizing external contract testing relationships to achieve superior quality, cost efficiency, and service delivery, aligning with company objectives.
  • Establishes and implements progressive quality, cost, and service targets for all laboratory operations, driving continuous improvement through the adoption of advanced laboratory systems, methodologies, and technologies.
  • Ensures all laboratory operations adhere to state and federal regulations while fostering the growth of internal technical expertise and operational excellence through training and development initiatives.
  • Oversees the design and execution of robust stability programs to support research and development, technical transfers, and routine production, ensuring the accuracy and reliability of shelf-life data for commercial products.

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
  • Demonstrates strong leadership abilities, strategic planning, problem-solving, and collaboration skills, with a focus on continuous improvement and effective team management.
  • Possesses deep expertise in compounding pharmacy regulations (United States Pharmacopeia <797>, <795>, <800>), laboratory systems, testing methods (High-Performance Liquid Chromatography, Gas Chromatography, microbiological testing), and quality systems, with proficiency in Microsoft Office Suite and advanced data analysis.

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 10 years of experience in pharmaceutical quality control or assurance, including expertise in laboratory operations, regulatory compliance, and stability programs, with at least 2 years in senior leadership driving team management and strategic initiatives.
  • Bachelor’s degree in Pharmacy, Chemistry, Biology, Microbiology, or related field. Master’s degree in related field or Master of Business Administration.
  • Certified Quality Auditor (CQA) preferred.
  • 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/