Vice President, Quality & Regulatory Affairs

This position requires that the selected individual lives in, or is willing to relocate to, the Lexington/Central Kentucky area.
The Vice President, Quality & Regulatory Affairs (VPQRA) leads the Organization’s adherence to regulations and standards established by governing agencies (AABB, FDA, CLIA, State, OSHA, NRC, EU, etc.). KBC is seeking qualified candidates to fill this key executive leadership role which is responsible for our Quality Assurance (QA) program and regulatory compliance activities. The position has oversight of the QA department and team, and reports to the CEO.
Responsibilities:

• Provides leadership and supervisory oversight to assigned department, directing the fulfillment of standards, activities, and customer service.
• Ensures the quality of KBC products and services through the implementation of auditing and monitoring processes, and analysis of reports.
• Maintains current knowledge of proposed and active regulations and acts as resource to management in interpreting requirements; serves as primary contact and liaison for regulatory and accrediting agencies, managing communication, and reporting, and representing Organization during inspections.
• Oversees KBC’s training and competence assessment practices to ensure compliance with Standard Operating Procedures (SOPs), regulations, and standard.
• Administers document control/training system and the approval of SOPs.
• Responsible for the Occurrence Management (OM) program, including the documentation, tracking, and corrective action for applicable operational errors and incidents through point of resolution.
• Interacts with all internal departments, levels of the organization, and external parties in fulfilling objectives of the QA program.
• Reviews proposed changes in blood center methods, manufacturing, or instrumentation, including validation, change control, and risk assessment.
• Oversees Organization’s disaster plan; interacts with emergency management agencies and represents KBC in response exercises.
• Maintains involvement with industry networks and stakeholders, building relationships and participating in related events and activities.
• Pursues continuing education and stays apprised of industry trends and best practices.
• Visits other KBC locations to perform internal audits and inspections.

Qualifications:

• Minimum of a bachelor’s degree in Medical/Clinical Laboratory Science (MLS/CLS) with MT (ASCP) credential required; additional graduate degree highly preferred.
• 5 years of management experience with sufficient background in healthcare, laboratory, or other related area. Preference given to qualified candidates with blood banking experience.
• Advanced MS Office and Adobe proficiency with the ability to navigate and enter data in custom systems and web applications.
• Excellent communication and the ability to interact effectively.
• Strong content and analytical skills.
• Demonstrated knowledge of regulatory agency requirements.
• Ability to work flexible schedule to include occasional evenings and weekends and regular on-call rotation.
• Valid Kentucky driver’s license with clean driving record.
• Must live in or relocate to the Lexington/Central Kentucky area.

Benefits (All insurance coverage after 60 days):

• Medical/Dental/Vision/Life/Disability Insurance
• Flexible Spending Accounts/Health Savings Accounts (FSA/HSA)
• Cancer Insurance/Accident Insurance
• Retirement Plan with up to 10% employer contribution (after 1 year of employment)
• Immediate PTO Accrual
• Paid Holidays
• Employee Assistance Program (EAP)

We are an Equal Opportunity Employer (EOE). All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.