Director Of Quality Assurance And Regulatory Affairs

Job Description:

Mission: Supports the quality management system of the Center including people, production, quality control, validation, and expedition of PET & Therapeutic Radiopharmaceuticals. Ensures patient safety and an environment in accordance with the regulatory policies. Develops a safe environment in which staff are motivated to work and grow.

Main Responsibility

• Responsible for the maintenance of the quality management system.
• Ensures compliance with cGMP and radioprotection requirements.
• Supports all efforts required to ensure the quality of EVERY Radiopharmaceutical product
• Ensures adequate communication with the local authorities demonstrating regulatory compliance.
• Supports facility improvement of operations, policies & procedures.
• Implements maintenance, training, equipment & trouble shooting plan.

Competencies

• Possesses Graduate Degree in Regulatory Science, Global Health with Biology or Chemistry Background

Comprehensive knowledge of cGMP, 21 CFR 211, 212

• Leadership
• Results focused
• Problem solving ability
• Detail oriented
• Ability to work in a team environment with minimal supervision.
• Willingness to learn
• Quality focused
• Organizes work activities to complete assigned tasks.

Outputs of the Job/Deliverables

• Review documentation related to API and Drug Products on the needs of the CMO
• Release API and Drug products that meet acceptance criteria/specifications
• Review all source documents to ensure quality
• Quality and safety of PET and Therapeutic Drugs / API
• Procedure & documentation for internal auditing and generating responses to external inspections.

Others

• Shift and occasionally weekend work is required
• Ability to achieve a physical job

Contacts

• Reports to: RadioMedix Spica President / COO
• External: Regulatory Agencies, Technical Experts, Suppliers.

Work Environment:

• Location: RadioMedix Spica Center, 19705 Aldine Westfield Rd, Humble, TX and Richmond Office 9701 Richmond Ave, Houston, TX 77042
• Work Conditions:
  • The work environment consists of manufacturing, laboratory, and office spaces. The position will sometimes require more than forty hours of work per week. The position is paid as salary. The work period is typically an 8-hour shift between 8 AM and 5 PM, with breaks. However, the work schedule may require the employee to come in for second or third shift if needed.
  • Individuals in this position will be exposed to ionizing radiation; however, radiation safety training will be provided, and radiation monitoring is required and ongoing at the facilities. Any exposure will be within Federal and State limits. Individuals in this position are required to be able to function and maneuver within the work environment without placing self, product, or others at risk. The position requires physical strength and dexterity with the ability to climb on ladders and up on equipment for environmental service and maintenance responsibilities.
    

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