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Senior Quality Assurance Specialist

4 weeks ago

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

This is a critical role within our Global Quality Operations department, responsible for ensuring the highest standards of quality in our cell and gene therapy products.

Key Responsibilities:
  • Oversee the batch release process to ensure 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.
  • 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 to address quality issues, deviations, or non-conformances during batch release.
  • 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:
  • 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.
  • Proactive mindset and a commitment to continuous improvement in quality assurance processes and practices.
Work Environment:

This is a sedentary position (at least 50% of time) in a typical office environment and/or clinical lab environment. There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners, computers, and other office equipment.

Ability to sit, talk, walk, hear, and communicate verbally and in writing is required. Occasional lifting of objects up to 25 lbs is expected.

Physical Demands:
  • Communicating Verbally
  • Hearing
  • Keyboarding
  • Lifting
  • Near Visual Acuity
  • Pulling
  • Pushing
  • Sitting
  • Standing/Walking
  • Stooping
Work Authorization/Security Clearance Requirements:

Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment.

Affirmative Action/EEO Statement:

Immatics is an equal opportunity employer. All employment decisions, including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs.

We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.