Regional Quality Director
JOB TITLE: Regional Quality Director
CLASSIFICATION: Exempt
DEPARTMENT: Regulatory Affairs and Quality Assurance
REPORTS TO: Division Director, Field Quality
MANAGERIALLY RESPONSIBLE FOR: Plasma Center Quality Manager 
POSITION PURPOSE: The Regional Quality Director is responsible for overseeing the quality assurance functions and personnel at multiple plasma collection centers within a designated region. This role ensures compliance with FDA regulations (21 CFR Part 640), EU standards, and other applicable regulatory requirements. The Regional Quality Director will lead a team of center quality managers, develop and implement quality assurance strategies, and drive continuous improvement initiatives to ensure the highest standards of product quality and donor safety. The position requires strong leadership, expertise in regulatory compliance, and a focus on fostering a culture of quality across the plasma centers.
Essential Job Functions:

Leadership and Management:
  • Lead and manage the Center Quality Manager teams across multiple plasma centers, providing guidance, support, and direction to ensure high performance.
  • Develop and implement regional quality strategies and objectives aligned with company goals and regulatory requirements.
  • Lead, monitor, manage and drive continuous improvement of site and regional Quality KPl's.
  • Collaborate with Operations leadership to identify and implement mitigation strategies to ensure product quality, donor safety, and reduce compliance risks in underperforming sites.

Quality Assurance Oversight:
  • Oversee all quality assurance activities at the plasma centers, including deviation management, CAPA (Corrective and Preventive Actions) processes, change control, and documentation management.
  • Ensure proper investigation, documentation, and resolution of deviations, non-conformances, and CAPAs.
  • Support regulatory and customer inspections and maintain a state of inspection readiness.
  • Review and approve critical quality documents, including standard operating procedures (SOPs), work instructions, and validation protocols.

Data Analysis and Reporting:
  • Oversee the collection, analysis, and trending of quality data from plasma centers, using data to identify trends, potential risks, and opportunities for improvement.
  • Prepare and present regular quality performance reports to senior management, highlighting trends, risks, and recommended actions.
  • Use data-driven insights to prioritize and drive quality improvement initiatives.

Continuous Improvement:
  • Drive continuous improvement initiatives across the region’s plasma centers to enhance the effectiveness and efficiency of the Quality Management System (QMS).
  • Collaborate with cross-functional teams to identify, plan, and implement process improvements that reduce exceptions, improve product quality, and enhance operational efficiency.
  • Facilitate root cause analysis and problem-solving sessions to drive corrective and preventive actions.

Collaboration and Communication:
  • Collaborate with other regional directors, corporate quality leadership, and operational teams to ensure alignment of quality practices and policies.
  • Communicate effectively with all levels of the organization, providing clear and concise updates on quality performance, issues, and initiatives.

Training and Development:
  • Collaborate with Learning and Development department to implement training programs and tools for quality assurance personnel at the plasma centers to ensure understanding of regulatory requirements and quality standards.
  • Ensure that all staff are adequately trained and competent in their roles, maintaining training records and monitoring training effectiveness.
  • Mentor and develop center quality managers and staff, providing opportunities for professional growth and advancement.

Job Specifications:
  • Bachelor’s degree in life sciences or related field preferred. Other combinations of education and experience may be considered.
  • Three (3) years of job-related experience in a Biologics, drug manufacturing, medical device facility or FDA regulated environment required.
  • Three (3) years’ experience leading people required. Remote management experience preferred.
  • Demonstrated knowledge of FDA regulations (21 CFR Part 640 Subpart G Source Plasma) required.
  • Strategic thinker with demonstrated experience in the development and management of quality systems, exception identification and resolution, CAPA programs, and continuous improvement initiatives required.
  • Strong organizational skills and attention to detail required.
  • Excellent verbal, written, and interpersonal communication skills required.
  • Demonstrated decision-making ability required.
  • Proven skills in data analysis required.

Physical Requirements:
  • Ability to sit for extended periods of time
  • Ability to use a computer and other office equipment
  • Ability to occasionally lift and carry up to 20 pounds
  • Ability to reach, bend, and stoop as necessary
  • Ability to communicate effectively, both verbally and in writing
  • Ability to focus and concentrate on tasks for extended periods
  • Ability to travel up to 50% via airplane and/or vehicle
  • Ability to use assistive devices if needed for mobility or communication