Blood Center Headquarters (La Concha)
Hours Per Week:
GULF COAST REGIONAL BLOOD CENTER
Location: 1400 LaConcha Lane in Houston Texas 77054
TITLE/CODE: Compliance Manager
DEPARTMENT: Quality Assurance
SCOPE OF RESPONSIBILITY
Reporting to the Director - Quality Assurance, this position manages all aspects of the quality and compliance functions to include development, implementation and maintenance of the Quality System and compliance/regulatory matters.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following; other duties may be assigned. Management retains the discretion to add to or change the duties of the position at any time.
· Develops and executes the quality and compliance programs and oversees the implementation and maintenance of these programs throughout the organization.
· Administration of CLIA and Incident Management Programs
· Defines, institutes and/or assists in quality and compliance related in-services and training.
· Analyzes and manages implementation of quality and regulatory standards by collaboration with impacted departments; serves as a consultant or resource to the organization for quality and compliance issues.
· Prepares for and participates in various external assessments; performs internal assessments throughout the organization.
· Assists Director in the approval of SOPs, deviations, and training materials.
· Completion and reporting of all applicable incidents to the regulatory agencies and provides the organization with an analysis of quality and compliance programs through summary reports.
· Participates in quality system activities such as root cause analysis, corrective action planning, and process improvement development.
· Serves as primary QA Manager role for cGTP and Cellular Therapy activities.
· Serves organizational committees; and at the direction of the Director, manages special projects.
· Enforces The Blood Center's policies on EEO, Affirmative Action and Safety/Health.
· Provides coverage and oversite for the Director in their absence.
Must not pose a direct threat or significant risk of substantial harm to the safety or health of himself/herself or others. Must comply with all applicable safety rules and policies and be willing to report actual and potential safety violations to the appropriate supervisor or manager.
Must maintain regular and acceptable attendance at such level as is determined in The Blood Center’s sole discretion.
Full time: must be regularly available to work at least 8 hours per day, 40 hours per week, or such other days or hours per week as The Blood Center determines are necessary to meet business needs.
Overtime (applicable only to non-exempt positions)
Must be available and willing to work such overtime per day or per week as The Blood Center determines is necessary or desirable to meet business needs.
Weekend and Holidays
Must be available and willing to work such weekends and holidays as The Blood Center determines are necessary or desirable to meet its business needs.
Must occasionally be able to work at off site locations and to transport self to same.
Supervises Compliance Coordinator and QA Specialist. May act as supervisor in the absence of the Director. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND EXPERIENCE
Bachelor's degree (preferably in healthcare or quality) from an accredited college or university plus at least 5 years previous experience in biologics regulatory compliance or equivalent combination of education and experience. Must have extensive knowledge of quality system concepts, cGMP, cGTP, FDA (biologics) and CLIA regulations and the ability to demonstrate the execution of programs in support of ongoing compliance.
CERTIFICATES, LICENSES, REGISTRATIONS
Certified Quality Auditor (or eligibility for same)
Certified Quality Manager (or eligibility for same)
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to work with mathematical concepts such as probability and statistical inference. Ability to define problems, collect data, establish facts, and draw valid conclusions.
OTHER SKILLS AND ABILITIES
Ability to plan and manage multiple priorities simultaneously
Must be able to be subject to occasional on-call responsibilities
Ability to work independently and as part of a team
Computer literate: Microsoft Office, Incident Management software
POSITION DRIVING STATUS
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.
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 frequently exposed to blood and/or blood components, as well as any other biohazard materials. The employee is occasionally exposed to outside weather conditions and extreme cold. The noise level in the work environment is usually low.
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.