Director Quality Assurance & Regulatory Affairs

OneBlood • Orlando, FL

15h

About The Position

Overview Directs the implementation, maintenance, and administration of all quality assurance and compliance programs, in order to maintain the organization’s objectives and competitive position in the marketplace. Provides direction in accordance with regulatory agency requirements and the organization’s policies and procedures. Responsibilities The list of essential functions, as outlined herein, is intended to be representative of the duties and responsibilities performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position. Directs, manages, and monitors the Quality & Regulatory Affairs department to ensure all activities are in compliance with licensing and accreditation requirements Represents the organization to external regulatory agencies, serving as the primary contact during external inspections Reviews proposed changes to standards and regulations, administering implementation of applicable changes Oversees the design, execution, and acceptability of validation and qualification processes and procedures, including software systems Coordinates internal audits and process improvement activities, including tracking and trending events and activities Participates in the organization’s business development by evaluating new technical developments and proposing strategies to improve efficiency and enhance quality and safety Directly supervises management staff throughout the department. Qualifications To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Requirements

• Bachelor’s degree in medical technology, healthcare, chemistry, biology, biotechnology or related field from an accredited college or university
• Ten (10) or more years of progressively responsible management experience in quality & regulatory affairs, preferably in a blood bank environment; or an equivalent combination of education, certification, training, and/or experience.
• Knowledge of and ability to interpret and apply federal and state regulations as they relate to quality and regulatory affairs
• Ability to formulate, initiate, and administer policies and procedures for effective fiscal control
• Ability to develop and interpret budgets, contracts, and financial reports
• Ability to organize work for timely completion
• Ability to speak, write, read, and understand English
• Ability to follow complex oral and written instructions
• Ability to communicate effectively orally and in writing
• Ability to delegate, manage and supervise effectively
• Ability to work with minimal supervision
• Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work
• Skill in operating office equipment
• Basic computer knowledge including Microsoft Office applications
• Ability to travel up to 20% of the time, including occasional overnight stays
• Ability to commute with personal transportation.

Nice To Haves

• Master’s degree preferred.
• Florida Supervisor’s license in Immunohematology, SBB and ASQ certification preferred.

Responsibilities

• Directs, manages, and monitors the Quality & Regulatory Affairs department to ensure all activities are in compliance with licensing and accreditation requirements
• Represents the organization to external regulatory agencies, serving as the primary contact during external inspections
• Reviews proposed changes to standards and regulations, administering implementation of applicable changes
• Oversees the design, execution, and acceptability of validation and qualification processes and procedures, including software systems
• Coordinates internal audits and process improvement activities, including tracking and trending events and activities
• Participates in the organization’s business development by evaluating new technical developments and proposing strategies to improve efficiency and enhance quality and safety
• Directly supervises management staff throughout the department.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager