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Field Quality Manager

1 month ago

Meridian, United States Proesis Biologics Inc Full time
Job DescriptionJob DescriptionDescription:

Proesis Biologics is a contemporary and forward-thinking human source plasma collection platform dedicated to improving the plasma donation journey for all stakeholders. We partner with communities and donors to supply the industry with the high-quality plasma necessary for treating people with rare and chronic conditions worldwide. We strive to create a collaborative and engaging culture focused on bold authenticity, intense curiosity and innovation, fierce donor advocacy, and growth.


The Proesis Bio team is searching for a Field Quality Manager (FQM) with immaculate attention to detail and strong leadership skills to oversee our current and future Proesis Bio plasma centers. The FQM is an essential quality and regulatory team member reporting to the Vice President of Quality and Regulatory. This position will serve as the liaison between Center Leadership and the corporate quality and regulatory team in quality matters. The Field Quality Manager ensures compliance with various governmental and regulatory agencies and proactively develops quality systems throughout the centers. This team member will work closely with the Field Operations Manager to ensure and develop strong growth within current and future Proesis Bio plasma centers.


Enough with the formalities. Are you ready to work for an organization that truly values you as a person, not just a worker? We don’t simply say our employees are our most valuable resource, we live it with emphasis on providing outstanding benefits related to your time (our PTO and paid Holidays are legit); health and dental insurance; wages (some sources show we pay in the top 10-15% of the market); and much, much more. By joining our team at Proesis Bio, you will not only be embarking on an exciting professional journey, but you'll also have the chance to make a real, tangible difference in the lives of people across our global communities, each and every day. If we have your attention, please continue reading to learn more about the role.

Requirements:

Role and Responsibilities:

  • Lead, manage and develop center leadership teams; directly manage Quality Assurance Managers.
  • Prepares, edits, revises and implements Standard Operating Procedures (SOPs) based on process improvements and changes in regulatory requirements.
  • Analyzes deviations, tracks internal and external inspection findings, and trends data to identify potential issues.
  • Aids in the development of effective corrective and preventive actions.
  • Proactively ensures compliance and inspection readiness across donor center support functions and donor center operations.
  • Represents organization during regulatory inspections and provides leadership during audits.
  • Experienced in developing CAPAs for internal and external audits.
  • Provide oversight to effectively open new collection centers and operate within the scope of FDA cGMP 21CFR.
  • Analyze data to identify performance gaps or areas of opportunity; use data to design performance improvement plans and center initiatives
  • Work cross functionally within the organization, especially with the Field Operations Manager, to appropriately meet regulatory requirements and operational goals while ensuring employee and donor safety.
  • Ensure marketing plans are executed as designed and work closely with Marketing on lead generation and donor retention strategies.
  • Instill company core values into plasma center operations.
  • Ensure legal and ethical conduct in centers as well as compliance with all corporate standard operation procedures and corporate processes.
  • Assist or lead in the opening of new locations for Proesis Bio.
  • Directing multiple center locations through inspections, collection growth, Effectiveness Checks, and project completion while maintaining a high level of quality.
  • Create, manage, and track all aspects of projects. This includes maintaining project schedules, managing project plans, resource plans, and status reports.
  • Communicate and collaborate with key stakeholders to ensure expectations and timelines are achieved. Identify, execute, and communicate risks associated with the project plan.
  • Lead and participate in continuous improvement activities to maximize business results.

Qualifications and Education:

  • Bachelor’s Degree
  • Minimum 5 years progressive responsibility as a manager in a highly regulated environment including direct supervision of employees performing enforceable standard operating procedures (SOPs) and Good Manufacturing Practices (cGMPs); experience managing remote employees performing these duties preferred
  • Previous experience managing a plasma center or biologics operations; regional management experience preferred
  • Frequently required to travel overnight – up to 50%


At Proesis, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community.