Senior Director, Quality Control (Hybrid)
Location: Hybrid - Houston, Texas, United States
Posted: May 1, 2025
Job Type: Full Time
Req# 2951
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 SummaryThe Senior Director of Quality Control ensures excellence in quality control, driving compliance, precision, and innovation while fostering accountability and continuous improvement. This role advances Empower's mission to deliver safe, affordable medications and shape the future of compounding pharmaceuticals.
Duties and Responsibilities- Leads the design and implementation of robust quality control systems, ensuring compliance with current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) regulations, and United States Pharmacopeia (USP) standards to consistently deliver safe and effective pharmaceutical products for all Empower internal laboratories as well as any external contract laboratories.
- Develops, builds, and executes both internal and external chemistry and microbiological testing strategies encompassing raw material testing and release, in-process testing, finished product testing, environmental monitoring, and stability testing across all life cycle stages optimizing cost, quality, and service while leveraging cutting-edge technologies and methodologies to guarantee precision and accuracy.
- Collaborates with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs, to drive process improvements, resolve quality issues, and ensure alignment with organizational goals and compliance requirements.
- Manages investigations of deviations, out-of-specification results, and other quality-related events, providing root cause analysis and implementing corrective and preventive actions to prevent recurrence.Oversees the hiring, onboarding, training, development, retention, and performance of the quality control team, fostering a culture of accountability, continuous learning, and excellence to meet the demands of a dynamic and regulated environment.
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 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, analytical, and problem-solving skills, with the ability to communicate effectively across all levels of the organization and foster a culture of collaboration and accountability.
- Extensive knowledge of cGMP, USP standards, and FDA regulatory requirements, along with proficiency in analytical techniques, laboratory instrumentation, and electronic quality management systems.
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 15 years of experience in quality control within the pharmaceutical or biotechnology industry, with 8 years in a leadership role overseeing quality control teams and operations required.
- Requires a Bachelor’s degree in chemistry, microbiology, pharmaceutical sciences, or a related field; Master’s degree in quality management or a scientific discipline is strongly preferred.
- Certified Quality Auditor (CQA) preferred; Certified Pharmaceutical Industry Professional (CPIP) preferred; Regulatory Affairs Certification (RAC) strongly preferred; Lean Six Sigma Green Belt or Black Belt certification preferred; Certified Quality Engineer (CQE) 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 WellnessWe 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/ - Link Opens in New Tab