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Senior Quality Assurance Specialist

2 months ago

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

Join Immatics NV as a Senior Operational Quality Assurance Specialist and contribute to the development and implementation of quality assurance strategies, policies, and procedures specific to cell and gene therapy products.

Job Summary:

The primary purpose of this position is to perform internal audits of manufacturing/CMC procedures, track and maintain standard operating procedures, work instructions, lab notebooks, manufacturing data, and perform official batch and material release.

Key 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.
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.
  • At least 4+ years of Biotechnology and/or pharmaceutical industry experience is required.
  • 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.

Physical Demands:
  • Communicating Verbally - expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.
  • Hearing - the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.
  • Keyboarding - entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens, and others.
  • Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object - usually by holding it in the hands or arms but may occur on the shoulder.
  • Near Visual Acuity - clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
  • Pushing - Exerting force upon an object so that the object moves away from the object.
  • Pulling - Exerting force upon an object so that the object moves toward the force.
  • Sitting - remaining in a sitting position for at least 50% of the time.
  • Standing/Walking - remain on one's feet in an upright position at a workstation.
  • Stooping - occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.
Equal Opportunity Employer:

Immatics NV 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.