Vice President, Quality and Regulatory Affairs - Biomedical Services American Red Cross 8/18/2016
American Red Cross
JOB DESCRIPTIONAPPLY The Biomedical Services Division plays a critical role in our nation's health care system. It is the largest single supplier of blood and blood products in the United States, collecting and processing more than 40 percent of the blood supply and distributing it to some 2,600 hospitals and transfusion centers nationwide. The Vice President, Quality & Regulatory Affairs (VP, Q&RA) position is open due to the retirement of a tenured organizational leader. The VP, Q&RA will be responsible for partnering with the Executive Vice President of the $2.7B Biomedical Services Division to preserve and continue to improve the quality of Biomedical Operations. This position is the organization's expert on quality and regulations and requirements for the industry, overseeing quality and compliance across the organization. The VP, QR&A will also play a key role as a thought leader and strategist to identify new approaches to quality in the organization and create a proactive environment around quality and regulatory matters.
The VP, Q&RA is responsible for overseeing global quality strategy and policy development, and leads a national team of about 450 around the country in the execution of these strategies and processes. The position has responsibility for developing, implementing and communicating the organization's quality strategy and programs, including quality assurance and, on a broader basis, total quality management throughout the organization. The role is also responsible for translating the organization's quality strategy into tactical policies, processes and procedures to meet global regulatory, medical/health and legislative standards.
* 15+ years of experience in quality assurance or related field
* 7years minimum experience in a senior leadership role with high level of responsibility for the overall quality and regulatory affairs programs and strategies
* Experience in a quality assurance and regulatory affairs role within a complex regulated blood bank, pharmaceutical, biotech, medical devices, diagnostic, or similar organization
* Demonstrated extensive experience successfully interfacing with the FDA and managing projects from submission to approval in challenging regulatory environment.
* Experience with blood banking preferred but not required
* Demonstrated leadership without direct line authority
* Proven success at managing complexity and diverse teams
* Excellent organizational, critical thinking, and negotiating skills
* Collaborative style with strong ability to influence
* Experience in team leadership and development
* Experience in a fast-paced, matrix environment
* Demonstrated excellence in written/oral communication skills across all levels
* Alignment with the mission and values of the organization
ADDITIONAL INFORMATION: Excellent base salary and performance based bonus plan aligned within the organization, Vacation, holidays, healthcare benefits, 401k matched plan