Quality Assurance Director

Company: Gulf Coast Regional Blood Center
Location: Houston
Posted on: November 13, 2024

Job Description:

GULF COAST REGIONAL BLOOD CENTERLocation: 1400 La Concha Lane in Houston Texas 77054Position Title: Quality Assurance DirectorJoin 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 services.JUST 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:
    • Ensure 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.
    • Design and implement procedures or programs to ensure compliance with international, federal, state and local regulations, directives, guidelines and standards. Provide organizational leadership related to the requirements and monitoring of applicable regulatory and accrediting agencies. Communicate applicable regulatory and accreditation changes to departments.
    • Prepare for and participate in audits and inspections.
    • Develop and implement quality training programs for the organization.
    • Review and approve 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.
    • Prepare, develop and manage Quality Assurance Budget.
    • Evaluate incident reports to ensure issues are appropriately investigated, resolved, corrected, and documented. Participate in decisions to determine blood and component suitability for use, distribution, or recall.
    • Incorporate quality management process improvement methodologies, such as lean and six sigma.
    • Foster a culture of quality and continuous improvement within the organization.
    • Foster a strong understanding of Quality Assurance principles and methodologies.
    • Be 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 of 7 years in progressively responsible management positions within a highly regulated industry.
      • Exceptional interpersonal and customer service 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 DEMANDSThe 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 ENVIRONMENTThe 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 STATEMENTThe 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.
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Keywords: Gulf Coast Regional Blood Center, Baytown , Quality Assurance Director, Accounting, Auditing , Houston, Texas