Manager, Quality Operations

Position Summary

The Manager, Quality Operations ensures high standards in Empower’s aseptic filling and finishing operations, leading the quality assurance team to drive first-time right processes and compliance. This role optimizes batch release, investigates deviations, and fosters continuous improvement to support Empower’s mission of delivering innovative, high-quality medications

Duties and Responsibilities

• Leads the quality assurance team in aseptic sterile filling and finishing operations to ensure on-the-floor quality and first-time right processes.
• Manages the batch release team, ensuring compliance with documentation, procedures, and regulations, and optimizing the batch release process to meet cycle time goals.
• Oversees the training and cross-training of Quality Operations staff, ensures compliance with sterility testing, aseptic techniques, and media fill process validations, and serves as a subject matter expert in the preparation and revision of procedures.
• Drives continuous improvement by implementing streamlined processes in compounding, validation, and risk assessments, and utilizes Corrective and Preventive Actions (CAPA) to resolve issues and enhance quality.
• Manages investigations into deviations, complaints, and manufacturing excursions, ensuring compliance with standards, and maintains quality records for ongoing audits and reviews.
  
  

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, effective communication, and organizational skills, with the ability to work both autonomously and as part of a team to resolve problems.

Possesses in-depth knowledge of pharmaceutical manufacturing, United States Pharmacopeia , current good manufacturing practices, 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.

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 quality, including 3 years in a supervisory role, with experience in international regulatory agencies highly desirable.
• Bachelor of Science degree in a technical or scientific discipline with 7 years of experience in pharmaceutical quality, including at least 3 years in a supervisory role, or a minimum of 10 years of experience in pharmaceutical quality, including at least 3 years in a supervisory role.
• Preferred American Society for Quality (ASQ) certifications, such as Certified Quality Auditor, Certified Manager of Quality/Organizational Excellence, or Software Quality Assurance Registered Quality Assurance Professional.
• 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.
  
  

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/