Senior Quality Assurance Specialist for Cell and Gene Therapy Manufacturing

5 days ago

Houston, Texas, United States Immatics NV Full time
Job Summary

We are seeking an experienced Senior Quality Assurance Specialist to join our team at Immatics NV. As a key member of our Global Quality Operations department, you will play a critical role in ensuring the quality and compliance of our cell and gene therapy products.

About the Role

This is a sedentary position in a typical office environment and/or clinical lab setting. The successful candidate will be responsible for performing internal audits of manufacturing procedures, tracking and maintaining standard operating procedures, work instructions, lab notebooks, and manufacturing data. They will also be involved in reviewing and approving batch records, analytical data, and associated documentation to ensure accuracy, completeness, and compliance with relevant regulations and guidelines.

Main Responsibilities
  • Oversee the batch release process for cell and gene therapy products, ensuring compliance with regulatory requirements, industry standards, and company policies.
  • Review and approve batch records, analytical data, and associated documentation to ensure accuracy, completeness, and compliance with relevant regulations and guidelines.
  • Conduct thorough quality checks on cell and gene therapy products, including verification of identity, potency, purity, and safety attributes.
  • Collaborate closely with cross-functional teams, including manufacturing, quality control, regulatory affairs, and clinical operations, to address any quality issues, deviations, or non-conformances during batch release.
  • Ensure appropriate corrective and preventive actions are implemented for identified quality issues and deviations.
  • Maintain and update batch release procedures, protocols, and documentation in accordance with current regulatory guidelines and industry best practices.
  • Provide guidance and support to junior members of the quality assurance team, including training, mentoring, and performance evaluation.
  • Participate in internal and external audits, inspections, and regulatory submissions, providing necessary documentation and information.
  • Contribute to the development and implementation of quality assurance strategies, policies, and procedures specific to cell and gene therapy products.
Requirements

To be successful in this role, you will need:

  • A Bachelor's degree in pharmaceutical sciences, life sciences, bioengineering, or a related field.
  • Extensive experience (4+ years) in quality assurance, preferably within the cell and gene therapy industry, or biopharma with a focus in batch release.
  • Strong knowledge of regulatory requirements and guidelines specific to cell and gene therapy products, such as FDA regulations, EMA guidelines, and ICH guidelines.
  • Familiarity with relevant standards, such as cGMP (current Good Manufacturing Practice) and GCP (Good Clinical Practice).
  • In-depth understanding of cell and gene therapy manufacturing processes, including cell culture, gene delivery systems, and viral vectors.
  • Proficient in reviewing and interpreting analytical data, batch records, and technical documentation related to cell and gene therapy products.
  • Experience in managing deviations, investigations, and CAPA (Corrective and Preventive Actions) processes.
  • Excellent communication and collaboration skills, with the ability to work effectively across cross-functional teams and interact with regulatory agencies.
  • Strong attention to detail, problem-solving abilities, and the ability to prioritize and manage multiple tasks simultaneously.
What We Offer

As a Senior Quality Assurance Specialist at Immatics NV, you can expect a competitive salary range of $120,000 - $160,000 per year, depending on experience, plus benefits including health insurance, retirement savings plan, and paid time off.

Our company is an equal opportunity employer and welcomes applications from diverse candidates. If you are a motivated and experienced professional looking to make a difference in the field of quality assurance, please submit your application.

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