Quality Assurance Director
: Job Details :

GULF COAST REGIONAL BLOOD CENTER Location: 1400 La Concha Lane in Houston Texas 77054 Position Title: Quality Assurance Director Join our team of heroes!Reporting to the Associate Vice President of Quality Services, this position oversees and directs all aspects of Quality Assurance and Compliance at The Blood Center to support the blood center's ability to provide safe, quality products and servicesJUST FOR YOU:

• Competitive compensation and benefits package.
• Texas Medical Center location with free parking.
• Engaging and exciting opportunity to SAVE LIVES.

Tips to thrive in our culture:

• Embody our Core Values of Commitment, Integrity, and Respect
• Work to actively create experiences that inspire others to save lives, each and every day.
• Embrace doing it right, making connections, and creating desired experiences.
• Comply with all organizational policies and standards, including safety rules, and be willing to report actual and potential violations to the appropriate supervisor or manager.

In this role, you will:

• Ensures excellence in blood banking practices and compliance with the Food and Drug Administration regulations (cGMP/cGTP), AABB Standards, international regulations, and Foundation for the Accreditation of Cell Therapy (FACT) standards.
• Designs and implements procedures or programs to ensure compliance with international, federal, state and local regulations, directives, guidelines and standards. Provides organizational leadership related to the requirements and monitoring of applicable regulatory and accrediting agencies. Communicates applicable regulatory and accreditation changes to departments.
• Prepares for and participates in audits and inspections.
• Develops and implements quality training programs for the organization.
• Reviews and approves standard operating procedures, validation plans and results, corrective action plans associated with audits and events, and other required documents for compliance as required.
• Lead root cause analysis and problem-solving activities
• Prepares, develops and manages Quality Assurance Budget
• Evaluates incident reports to ensure issues are appropriately investigated, resolved, corrected, and documented. Participates in decisions to determine blood and component suitability for use, distribution, or recall.
• Incorporates quality management process improvement methodologies, such as lean and six sigma.
• Foster a culture of quality and continuous improvement within the organization
• Fosters a strong understanding of Quality Assurance principles and methodologies
• Responsible for organization-wide FDA contact, product licensure submissions and 483 inspection observation responses; FDA Designee and Appointee.

We need someone who has:

• Bachelor's degree (preferably healthcare or quality management) from an accredited college or university; Graduate degree is strongly preferred.
• Experience must include a minimum 7 years in progressively responsible management positions within a highly regulated industry.
• Exceptional interpersonal and customer services skills are required. Ability to determine priority of goals for multiple projects and ability to maintain perspective in unusual or stressful situations are essential characteristics.
• Excellent oral and written communication skills are required to successfully interact with employees, management, regulatory agencies, and the public.
• Professional certification with American Society of Clinical Pathologists (ASCP) or equivalent professional affiliations preferred
• Professional certification with American Society for Quality preferred
• Green Belt Certification or equivalent experience preferred.

PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is frequently required to operate a computer and other office machinery and remain in a stationary position. The employee must frequently lift and/or move up to 10 pounds. Employees are required to be familiar with and abide by the team lift requirements as specified in the Safety Program. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, blood and/or blood components, as well as any other bio-hazardous material. Possible exposure to radiation. The noise level in the work environment is usually low.Think you have what it takes to save lives with us? We want to hear from you.EQUAL OPPORTUNITY EMPLOYER STATEMENT The Blood Center is an Affirmative Action/Equal Employment Opportunity Employer. Qualified applicants for positions are considered without regard to race/ethnicity, color, religion, national origin, age, pregnancy, sex, sexual orientation, gender identity, transgender status, military status, protected veteran status, disability status, genetic testing results or any other basis or characteristic prohibited by applicable law, statute, regulation or Executive Order.