Director Quality Assurance & Regulatory Affairs

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.

*This position can be based in Tallahassee, St Pete, Orlando, Jacksonville, Fort Lauderdale or Charlotte, NC*

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.

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.

EDUCATION AND/OR EXPERIENCE:

Bachelor's degree in medical technology, healthcare, chemistry, biology, biotechnology or related field from an accredited college or university; Master's degree preferred. 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.

CERTIFICATES, LICENSES, REGISTRATIONS AND DESIGNATIONS:

Florida Supervisor's license in Immunohematology, SBB and ASQ certification preferred.

KNOWLEDGE, SKILLS AND ABILITIES:

• 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.

PHYSICAL REQUIREMENTS:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Ability to exert light physical effort in sedentary to light work, which may involve some lifting, carrying, pushing and/or pulling of objects and materials of light weight (up to 20 pounds).

ENVIRONMENTAL REQUIREMENTS:

The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job.

Functions are regularly performed inside without potential for exposure to adverse conditions, such as inclement weather, atmospheric elements and pathogenic substances. The noise level in the work environment is usually moderate.

OneBlood is an Equal Opportunity Employer/Vet/Disability/Other Protected Categories