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Senior Quality Assurance Specialist

2 months ago

Houston, Texas, United States Immatics NV Full time
Job Title: Senior Quality Assurance Specialist

Join Immatics NV as a Senior Quality Assurance Specialist and play a critical role in ensuring the quality and compliance of our cell and gene therapy products.

Key Responsibilities:
  • Oversee the batch release process for cell and gene therapy products, ensuring compliance with regulatory requirements, industry standards, and company policies.
  • Independently author and review deviations, driving process improvements and managing complex deviation investigations.
  • Collaborate closely with cross-functional teams to address quality issues, deviations, or non-conformances during batch release.
  • Communicate effectively across multiple groups and levels to drive deviation closure and provide regular progress updates.
  • Identify interdepartmental process improvements and work cross-functionally to implement them.
  • Manage multiple priorities either independently or as part of a team to meet key deadlines and communicate issues and progress across all levels of the organization.
Requirements:
  • Bachelor's degree in pharmaceutical sciences, life sciences, bioengineering, or a related field.
  • At least 6+ years of Biotechnology and/or pharmaceutical industry experience, preferably in quality assurance.
  • Strong knowledge of regulatory requirements and guidelines specific to cell and gene therapy products.
  • Familiarity with relevant standards, such as cGMP and GCP.
  • Excellent communication and collaboration skills, with the ability to work effectively across cross-functional teams and interact with regulatory agencies.
What We Offer:
  • A dynamic and innovative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

Immatics NV is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment that values diversity and promotes equal opportunities for all employees.