Senior Operational Quality Assurance Specialist - 2nd Shift (1012)

FLSA Classification : Exempt / Salary

Schedule : Monday - Friday; 1400 - 2230; On-Site (Eligible for one day of WFH per week after the successful completion of the 90-day probationary period).

Department : Global Quality Operations

Reports to : Operational Quality Assurance Manager

Supervisory responsibilities : No

Location : 13203 Murphy Road Suite 100 Stafford, TX 77477

Position Summary / objective :

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.

Essential functions :

• 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.
• Identify opportunities for process improvements, risk mitigation, and increased efficiency in the batch release process.
• Stay up to date with the latest advancements, regulations, and best practices in the field of cell and gene therapy manufacturing and quality assurance

Competencies :

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 :

Required education and experience :

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."

Other duties :

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description may not cover all duties that take place on a daily basis and may be changed as business needs change. Employee will be responsible for adapting and learning the duties as described above or as the new ones are introduced.