Director of Quality Assurance

Director Of Quality Assurance

RadioMedix Inc., a biotechnology company headquartered at 9701 Richmond Ave Houston, Texas 77042, is seeking a Director of Quality Assurance. The successful candidate will play a key role in conducting quality assurance review of all drug products on site. The focus of the position will be to focus on high-priority projects at RadioMedix that will be integral to upcoming clinical trials. This is a newly created position with potential for significant growth.

We're a growing company and we continue to add talent from a variety of fields. RadioMedix seeks to hire highly motivated and forward-thinking professionals interested in nuclear medicine research and development and influencing change within the Nuclear Medicine landscape.

Key Responsibilities :

Quality Management Systems (QMS) Development :

• Establish and maintain a robust QMS to ensure all radiopharmaceutical products comply with regulatory standards (FDA, EMA, and ICH) including 21 CFR Parts 210, 211, and 212.
• Implement and oversee risk management processes, change control, and document management systems.

Regulatory Compliance :

Quality Control Oversight :

Product Release and Batch Review :

Quality Events and Investigations :

Training and Development :

Continuous Improvement :

Cross-functional Collaboration :

Requirements :