Job Board

Position Overview

The Director of Regulatory Affairs and Quality Compliance provides leadership with regulatory guidance ensuring ongoing compliance for the organization. Leads the Quality Unit staff by coaching, managing, monitoring, and evaluating compliance activities. Promotes ongoing compliance and effective processes ensuring adherence to applicable regulations and standards.

Essential Functions

• Collaboratively supports organizational systems, processes, and the quality goals of the company
• Networks with other organization’s regulatory and compliance personnel and associations TBC is affiliated
• Monitor the release of new or revised regulations and standards, evaluating the impact on current processes and practices, and recommend changes if necessary to ensure continual compliance
• Participate in change management process providing guidance and support the change is executed meeting regulatory compliance and ensuring continuous improvement
• Prepares regulatory licensing submissions for processes or blood products manufactured with the intention of interstate commerce.
• Maintains training materials supporting organizational understanding of current good manufacturing practices
• Evaluates and contributes in the preparation of competency evaluations of operational staff meeting regulatory and accrediting requirements
• Evaluates investigations of incidents/occurrences reported and participates in the investigation, root cause analysis and development of corrective action plans.
• Ensures the notification of regulatory or accrediting agencies of significant occurrence events
• Develops and implements process control measures such as:
• Process Flow Charts
• Written controlled policies, process descriptions and procedures
• Monitors and benchmark comparisons of operating conditions
• Provide tracking and trending of events allowing for continuous improvement
• Reviewing validation results and providing approval of new processes and equipment for use
• Serves as a point person for external assessments.
• Effectively communicates with assessors and TBC executive management, directors, and managers during an external assessment
• Directs the execution of internal assessments for organization’s systems and processes promoting compliance and readiness for external assessments
• Participate and review reports of suspected post transfusion adverse reaction. Providing guidance on the investigation and execution of required product recalls and withdrawals
• Maintains and sustain harmony with operational and support functions serving as an advocate and resource for staff and operations
• Directs Quality Unit completing quality role tasks providing guidance and development of their skills
• Evaluates employee qualifications, requirements, and performance in terms of job accountability coaching, counseling, and disciplining as required.

Minimum Qualifications

• Bachelor’s Degree in Biology, Management, or related field
• ASQ Certification desirable
• At least five years progressive experience in a blood center or related field
• Management experience required
• Ability to communicate effectively, tactfully, and courteously to patrons, donors, sponsors, and co-workers
• Ability to organize and prioritize workload and meet deadlines
• Excellent analytical skills
• Ability to work with all levels and in a diverse work environment
• Foster and maintain effective working relationships with staff, management, and peers
• Ability to exercise discretion on sensitive and confidential matters