Manager of Quality Assurance Strategies

Overview

Versiti is a unique blend of donors, scientific exploration, and precision healthcare, recognizing the invaluable contributions of blood and life. We host the esteemed Blood Research Institute, facilitating life-saving donations from our supporters and delivering the scientific foundation for medical practices through our diagnostic laboratories. Versiti unites exceptional talents with unmatched expertise in transfusion medicine, transplantation, stem cell and cellular therapies, oncology, genomics, diagnostic lab services, and medical and scientific knowledge. This amalgamation of skills and insights leads to enhanced patient outcomes, superior service quality, and reduced healthcare costs for hospitals, blood centers, healthcare systems, research institutions, and other medical providers. At Versiti, we are dedicated to elevating patient lives and empowering our healthcare partners.

Position Summary

The Manager of Quality Management Systems plays a pivotal role in orchestrating and executing advanced quality operations, primarily tasked with overseeing intricate quality initiatives, systems, and strategies. Responsibilities may encompass reviewing and endorsing policies and procedures, validating software supporting quality functions, assisting in planning, approving deviations, corrective and preventive actions, and change control, as well as fulfilling subject matter expert duties. This position may also serve as a delegate for higher-level quality functions as designated in job responsibilities. The manager is accountable for supervising assigned direct reports, conducting personnel performance evaluations, and participating in hiring and termination decisions within the Quality division.

Responsibilities

• Core Quality Responsibilities
  • Cultivates and promotes a work atmosphere that fosters adherence to the Quality Policy and Quality Plan alongside documented quality processes and procedures.
  • Offers guidance, coaching, and mentorship to team members to fulfill organizational objectives.
  • Develops direct reports by securing suitable training, assigning progressively challenging tasks, applying necessary disciplinary actions, and conducting formal performance evaluations.
  • Supports quality enhancement projects identified and developed by Quality personnel.
  • Encourages and maintains a culture of continuous improvement practices, leading a team in identifying and implementing enhancements to quality systems, compliance, regulatory affairs, and educational activities.
  • Oversees operations of the sub-organization for which they are responsible and provides direction as needed.
  • Leads internal and external assessments, facilitating optimal communication between the department and investigators or assessors.
  • Allocates resources for actions identified based on quality metrics.
  • Identifies and formulates quality improvements.
  • Reviews and endorses standard operating procedures, validation plans and results, corrective action plans related to audits and events, and other compliance documents as necessary.
  • Champions strategies and actions based on quality metrics.
  • Supports the execution of the Quality Management System.
• Specific Manager, Quality Management Systems Responsibilities
  • Responsible for the development and upkeep of the Quality Management System elements for Versiti, including but not limited to document and change management, events management, records management, change control, and validation.
  • Fosters a work environment that supports compliance with the Quality Policy and documented quality processes and procedures.
  • Manages quality personnel who implement the QMS on a daily basis.
  • Promotes a culture of continuous improvement, leading a team in identifying and implementing system and process changes that enhance operational efficiency and customer outcomes.
  • Assists direct and indirect reports and internal customers in interpreting Quality System and product information control procedures.
  • Establishes goals and objectives for all assigned personnel, monitors performance against these goals, and provides feedback.
  • Facilitates communication between functional departments to resolve issues effectively.
  • Provides leadership for the team responsible for the ongoing maintenance of enterprise quality management software, acting as a subject matter expert.
  • Drives quality systems improvements throughout the organization.
  • Analyzes, tracks, and trends quality data to ensure proactive responses to potential issues with enterprise quality management software.
  • Develops and reviews documentation necessary to communicate quality policies, processes, and procedures across the organization, ensuring controlled documentation is reviewed, approved, and published according to quality systems.
  • Integrates continuous improvement practices into quality systems, education, and improvement activities.
  • May support or conduct internal audits, analyze processes and procedures, perform risk assessments, and provide technical support to promote productivity improvements or cost reduction opportunities.
  • Leads and supports the integration, upgrades, and decommissioning of tools required to maintain an effective quality management system.
• Performs additional duties as assigned.
• Adheres to all policies and standards.

Qualifications

Education

• Bachelor's Degree (BS or BA) required.
• Master's Degree (MBA, MS, MA) preferred.
• Degree in information technology, computer software, programming, or related fields preferred.

Experience

• 7-9 years of overall experience required.
• 1-3 years of leadership experience required.
• 4-6 years of experience with a master's degree required.
• Experience in QMS, QA, QC, or Quality Auditing in environments such as blood banking, pharmaceuticals, medical devices, or hospitals required.
• Program leadership experience preferred.
• Familiarity with good practices for computerized systems in regulated environments preferred.

Knowledge, Skills, and Abilities

• Proven ability to read, interpret, and apply regulations and standards relevant to operations.
• Expert knowledge of professional concepts and company policies to resolve a variety of issues.
• In-depth understanding of GxP requirements preferred.
• Comprehensive knowledge of standardized rules and procedures across multiple service lines.
• Ability to determine actions based on guidelines and lead the development of new policies within the area of responsibility.
• Strong interpersonal and mentoring skills to effectively interact with and develop employees.
• Proven experience as a Quality Leader or Manager.
• Capacity to manage multiple projects simultaneously.
• Adaptability to changing organizational and operational needs, leading others through change.
• Ability to work under pressure in a fast-paced environment, meet deadlines, and make effective decisions.
• Strong communication skills, both verbal and written, and proficiency in Microsoft Office and other software applications.
• Knowledge of Electronic Document Systems preferred.

Licenses and Certifications

• Quality Certifications highly preferred.

Tools and Technology

• Personal Computer (desktop, laptop, tablet) required.
• General office equipment required.
• Proficiency in Microsoft Suite (Word, Excel, PowerPoint) required.
• Familiarity with software validation tools and technology required.