QA Manager, Cellular Life Solutions

GULF COAST REGIONAL BLOOD CENTER

Location: 1400 La Concha in Houston, Texas 77054

Position Title: Quality Manager - Cellular Life Solutions 

Join our team of heroes!

Reporting to the Director – Cellular Life Solutions (CLS), manages operational aspects of the quality and compliance functions to include development, implementation and maintenance of routine Quality System and compliance/regulatory activities.

JUST FOR YOU:

• Competitive compensation and benefits package.
• Texas Medical Center location with free parking.
• Work-life Balance:  Monday to Friday, 7-4pm or 8-5pm.
• 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:

• Develops, revises, and institutes and/or assists in quality and compliance related in-services and training
• Develops and executes the CLS departmental quality and compliance programs and oversees the implementation and maintenance of these programs.
• Assists Director in the approval of SOPs, deviations, and training materials.
• Manages CLS departmental quality program encompassing compliance and regulatory matters, cGMP/cGTP training, competency assessment and SOP development for assigned areas
• Analyzes and manages implementation of quality and regulatory standards in the department
• Prepares for, participates in, and manages departmental involvement in external assessments
• Manages, coordinates and performs department internal assessments
• Prepares CLS department QA plan and manages continued assessment and evaluation of effectiveness.
• Provides the department with an analysis of quality and compliance programs through summary reports
• Manages and actively participates in the change control process for all CLS activities by providing review, tracking, impact assessment and implementation for applicable areas.
• Serves as a consultant or resource to the organization for quality and compliance issues related to CLS
• Participates in incident management, root cause analysis, corrective action, and process improvement development
• Manages, actively participates in and contributes to improving operational efficiency, donor safety, departmental quality and customer satisfaction through collaboration with CLS leadership and staff. 
• Enforces The Blood Center's policies on EEO, Affirmative Action and Safety/Health
• Provides coverage and oversite for the Director in their absence.
• Complete additional duties as assigned.

We need someone who has:

• Bachelor's degree (prefer healthcare area) plus a minimum of 5 years previous experience in compliance or equivalent combination of education and experience. 
• Must have extensive knowledge of the Quality System concepts and FDA regulations.
• One-year certificate from an accredited college/technical school; minimum of two years of secretarial experience or related experience or equivalent combination of education and experience.
• Certified Quality Auditor (or eligibility for same) is preferred
• Certified Quality Manager (or eligibility for same) is 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.

The noise level in the work environment is usually moderate.

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.