Quality Assurance Compliance Manager

Position Overview

We are currently seeking a highly motivated Quality Assurance Specialist to join our team and support our efforts in developing cell-based therapies for the treatment of cancer. As a Quality Assurance Specialist, you will play a critical role in ensuring the daily oversight of quality operations and compliance with cGMP/GDP requirements for our partner blood banks and testing labs. Your expertise and guidance in GMP-compliance will be essential in maintaining the highest level of quality standards within our organization.

Responsibilities

 

• Provide daily oversight of quality operations, ensuring compliance with cGMP/GDP requirements.
• Support partner blood banks and testing labs in maintaining regulatory compliance.
• Guide and advise colleagues on GMP-compliance.
• Execute change control processes.
• Collaborate with suppliers to implement and manage quality programs.
• Apply problem-solving skills and attention to detail to address any compliance issues.
• Manage multiple tasks, ensuring timely and accurate completion.
  
   

Qualifications

 

• Bachelor's degree in biomedical or life sciences.
• Strong understanding of quality systems and quality management programs.
• Knowledge of FDA-CFR Title 21 and EU regulations.
• Familiarity with international and US/state/local cGMP and GDP guidelines.
• Excellent written and verbal communication skills.
• Experience in change control processes.
• Preferred experience with supplier quality programs.
• Strong problem-solving skills and attention to detail.
• Ability to work independently and handle multiple tasks efficiently.
  
   

If you are passionate about making a difference in the field of cell-based therapies and possess the necessary qualifications and skills, we encourage you to apply for this exciting opportunity. Join us in our mission to develop innovative cancer treatments and contribute to the advancement of medical science.

Employment Type: Contractor