Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.
Provides effective leadership to achieve high levels of service and product quality, financial results, and other criteria in accordance with policies, goals, and objectives.
Assists in hiring, supervision, training, development, and performance evaluation of assigned personnel. Identifies and effectively resolves personnel issues.
Ensures documentation of policies and procedures that govern all clinical services.
Facilitates, schedules, and manages functional council meetings.
Serves as liaison with vendors and seeks to maximize opportunities from vendors servicing the clinical services areas.
Facilitates activities with other functional VPs and Corporate Office areas (e.g., IT, Finance, Supply Chain, Marketing, HR, Operations, Quality, Facilities, etc.) to develop project scope, identify resource requirements, articulate deliverables, and establish timetables and priorities for Blood Services Projects and SOP revisions/implementations.
Oversees coordination/development of new or revised policies and procedures as required to assure delivery of quality products and services.
Oversees requests to FDA for variances, submission of SOPs for FDA review, evaluation of non-conforming products and evaluation and interpretation of evaluation draft guidance documents.
Manages production projects across multiple operating units. This includes initial evaluation, cost-benefit analysis/financial impact, resources management, implementation and outcome review for short and long-term projects.
Collaborates with department staff and other Blood Services departments to research, identify, and evaluate new products, devices, and methodologies to improve efficiencies, working conditions.
Ensures quality systems comply with current Good Manufacturing Practices, regulatory, industry, and BSI standards. Assists in the development, review, and approval of internal audits and responses to internal and external citations.
Develops and maintains familiarity with blood center operations. Requires periodic visits to blood center operating units to determine effectiveness of business systems support and opportunities for improvement.
Oversees the development and administration of operating and capital expenditure budgets.
Remains abreast of changes and developments in the blood banking industry related to regulations and standards and provides direction to implement required changes. Establishes and maintains a network of professional relationships.
Bachelor's degree required.
Master’s degree preferred.
Knowledge of large system operations management including fiscal policies, human resource management, and strategic planning required.
Knowledge of federal, state, and local regulations that affect business operations required.
SBB, RN or equivalent certification/licensure preferred.
Eight years of related experience required. To include:
Blood Systems is one of the nation’s oldest and largest comprehensive transfusion medicine organizations. We serve blood centers, hospitals and health systems, offering shared management and support services, quality excellence and effective contracting.
Strong. Diversified. Vertically integrated. A modern transfusion medicine organization, Blood Systems brings together the benefits of a lean a...nd effective centralized support structure, a national scope and close-to-the-customer decision-making authority.