Director, Information Systems Quality & Compliance
October 4, 2018
Full Time - Experienced
4 Year Degree
Vitalant, formerly Blood Systems, is one of the nation’s oldest and largest nonprofit transfusion medicine organizations.
Under minimal direction, this position is responsible for managing the review and approval of quality systems and compliance in all areas of computerized medical devices and computer applications for Vitalant and business units. This position provides subject matter expertise, consultation, guidance, coaching, and direction for computer related quality and compliance issues to process owners at Vitalant and business units.
DUTIES AND RESPONSIBILITIES:
Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.
Assures quality customer service to all customers.
Maintains good attendance and punctuality per the absence policy.
Provides effective leadership to achieve high levels of service and product quality, financial results, and other criteria in accordance with policies, goals, and objectives.
Hires, supervises, trains, and evaluates performance of assigned personnel. Develops assigned personnel and identifies / effectively resolves personnel issues.
Directs process evaluation and design activities for new or proposed processes as well as process changes in IT and/or identified operational subject matter areas. Oversees pre- and post-process change evaluations to address change risk and to validate improvements.
Directs the development and performance of internal audits of the IT department and vendor audits related to computer software and systems. Assists with external audits and facilitates responses to computer observations.
Ensures documents (e.g. IT SOPs, training, validations, test plans, matrices, etc.) meet regulatory standards and are reviewed and approved prior to implementation.
Participates in the evaluation, review, and/or selection of computerized medical devices and computer applications.
Ensures computer systems and changes to computer systems meet required regulations. Ensures Information Systems Quality and Compliance functions are applied to business units.
Ensures data is analyzed to identify and monitor problem areas. Presents findings to appropriate management. Participates in Six Sigma and other performance improvement initiatives as needed.
Assists in implementing the strategic plan. Provides direction regarding goal setting with short and long-term goals.
Participates in the annual budget preparation and ensures adherence to approved department budget.
Remains abreast of changes and developments in the IT and medical device industries related to regulations and standards and provides direction to implement required changes. Establishes and maintains a network of professional relationships.
Performs all other duties, at the discretion of management, as assigned.
Bachelor's degree required.
Knowledge of computer environments, standards development, and system life cycle methodology required.
Knowledge of project planning and control required.
Knowledge of regulations as they relate to the blood industry, quality, and/or information technology activities required.
Information Technology related certification (e.g. – ITIL, COBIT, CISA, CSQE, etc.) preferred.
Eight years of related experience in a regulated IT industry required. To include:
Three years of supervisory experience.
Four years of experience in IT quality, regulatory, and/or auditing.
Internal Number: 181382
About Blood Systems
Blood Systems is an internationally known leader in transfusion medicine founded on the principles of quality, excellence and service. Our headquarters are located in sunny Scottsdale, Arizona.Founded in 1943 as the Salt River Valley Blood Bank in Phoenix, Arizona, today Blood Systems is one of the nation’s oldest and largest non-profit transfusion medicine organizations.The Blood Services division, our largest, provides leadership, policy and shared services to its blood centers. It facilitates comprehensive blood service contracting for national and regional healthcare systems. Our blood centers provide blood, blood components and special services to patients in some 1,000 hospitals across the country.Blood Systems Research Institute generates and analyzes data to aid the US and worldwide transfusion community by recommending testing strategies and technology. Creative Testing Solutions, a joint venture, is the largest independent blood donor testing organization in the country with several high volume laboratories. The BioCARE division distributes therapeutic biologicals and recombinant coagulation factors, including such products as albumin, coagulation factors, fibrin sealants, IVIG and Rh immune globulin. Our CanyonCARE Rx specialty pharmacy is part of BioCARE.