Executive Director of Quality and Regulatory Affairs
The Executive Director of Quality and Regulatory Affairs leads the strategic vision which enables the organization to meet all applicable requirements, exceed all customer expectations, and ensure the organization strives for continuous improvement.
ESSENTIAL JOB FUNCTIONS:
Provides leadership and establishes a focused and knowledgeable quality staff which in turn leads the quality process for the company.
Implements best practices to achieve improvements in safety, cost, quality, lead-time and service.
Ensures proposed legislation and regulations are monitored for possible impact on the organization.
Evaluates the effectiveness of current processes and leads team to strive for continual ongoing improvement.
Facilitates the collection, aggregation and analysis of quality indicator data to provide a basis for internal and external bench-marking.
We offer a highly competitive benefits package including medical, dental, vision, life and supplemental insurance, 401(k) with employer contribution and match, and generous paid time off (PTO) - up to 4 weeks in your first year!
CBC began in Dayton in 1964 as the region’s first centralized blood bank. CBC collects and provides all blood products for hospitals in our 15-county region and beyond. CTS was born in 1986 and is now one of the nation’s largest tissue banks. CTS recovers, processes, and distributes human tissue grafts and is the nation’s largest non-profit provider of skin grafts for burn patients.
Community Blood Center/Community Tissue Services is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age, protected veteran status, disability status, or any other characteristic protected by law.
Drug Free Workplace
Bachelor’s degree in clinical or life science-related field or engineering.
5 years executive experience leading quality control, quality assurance, clinical laboratory, blood banking, tissue banking, pharmaceutical/other manufacturing environment or similar field.
Current and working knowledge of FDA, AABB, AATB, OSHA, CFT, ISO 13485 and the Medical Device Directive.
Master’s degree preferred (major in business, production/operations management).
Experience with Lean Manufacturing/Six Sigma/Toyota Production System continuous improvement methodologies.
Internal Number: EXECU01649
About Community Tissue Services
Community Tissue Services (CTS) is the largest nonprofit provider of skin grafts to surgeons for severe burn patients in the United States. We strive to be on the forefront of new graft development and biotechnology to better serve recipients and medical professionals. CTS is a quality, ethical provider of services to donor families, medical communities, recipients, and community partners through recovery, processing, and distribution of tissue grafts.