Supervisor, Quality Operations 503B (1st shift)

Position Summary:

As Supervisor of Quality Operations, you will lead with precision and accountability to uphold the highest standards in aseptic manufacturing and quality assurance. You will oversee critical quality systems-including deviation management, batch record review, and current Good Manufacturing Practices (cGMP) compliance-while championing a culture of continuous improvement and operational excellence. Your leadership will play a pivotal role in advancing Empower’s mission to deliver innovative, affordable medications that improve lives and broaden access to essential therapies.

Duties and Responsibilities:

• Supervises daily operations of Quality Operations, focusing on real-time floor oversight, batch record review, lot disposition, and investigation management for a three-shift aseptic sterile filling and finishing operation.
  
• Leads and improves batch release processes to ensure timely disposition within cycle times; streamlines compounding, validation, change control, laboratory processes, and risk assessment procedures.
  
• Acts as a quality subject matter expert for procedures and specifications, ensures team cross-training for environmental monitoring, and guides the team in achieving quality-first outcomes through incident and Corrective and Preventive Action (CAPA) processes.
  
• Leads direction of investigations into deviations, excursions, product non-conformances, and complaints; oversees root cause analysis and CAPA to address audit findings and drive continuous improvement.
  
• Reviews and approves change controls, test data, and deviation reports to ensure adherence to standards and regulations; reports findings to influence behavioral and operational change.
  

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 leadership, effective communication, and organizational skills, with the ability to work both autonomously and as part of a team to resolve problems.
  
• Possesses knowledge of pharmaceutical manufacturing, United States Pharmacopeia <797>, cGMP, Food and Drug Administration regulations (21 Code of Federal Regulations Parts 210, 211), and International Council for Harmonisation regulations, with proficiency in computer software, particularly SharePoint.
  

• 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.
  

• 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 3 years of experience in pharmaceutical quality, including 2 years in a supervisory role.
  
• Bachelor of Science degree in a technical or scientific discipline.
  
• American Society for Quality (ASQ) Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or an equivalent certification preferred.
  

Benefits:

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/