Senior Operational Quality Assurance Specialist

Immatics • Houston, TX

22h • Onsite

About The Position

We are seeking a Senior Operational Quality Assurance Specialist to support our Operational Quality Assurance & Systems team. This role is responsible for ensuring quality and compliance across manufacturing and CMC activities by conducting internal audits and supporting batch and material release processes. You will maintain and manage key documentation, including standard operating procedures, work instructions, lab records, and manufacturing data, while helping uphold high standards in a regulated environment.

Requirements

• Bachelor’s degree in pharmaceutical sciences, life sciences, bioengineering, or a related field
• 4+ years of experience in quality assurance within biotechnology or pharmaceutical environments, including batch release activities
• 4+ years of experience working in regulated environments with cGMP and GCP standards
• Demonstrated experience reviewing batch records, analytical data, and technical documentation for product release
• Proven experience managing deviations, investigations, and CAPA processes
• Legal eligibility to work in the United States

Nice To Haves

• Advanced degree (Master’s or higher) in pharmaceutical sciences, life sciences, bioengineering, or a related field
• Experience in cell and gene therapy or advanced therapeutics within a GMP-regulated environment
• Strong knowledge of global regulatory requirements (e.g., FDA, EMA, ICH) for biologics or advanced therapies
• Advanced ability to interpret complex manufacturing and analytical data to support quality decisions

Responsibilities

• Oversee batch release activities for cell and gene therapy products, ensuring compliance with regulatory requirements and company standards
• Review and approve batch records, analytical data, and documentation for accuracy, completeness, and compliance
• Perform quality checks to verify product identity, potency, purity, and safety attributes
• Collaborate cross-functionally to resolve quality issues, deviations, and non-conformances
• Drive CAPA implementation and support continuous improvement of batch release processes
• Maintain and update procedures and documentation in line with regulatory guidelines and best practices
• Support audits, inspections, and regulatory submissions, and provide guidance to junior QA team members

Benefits

• Competitive rates for Health, Dental, and Vision Insurance
• 4 weeks of vacation granted up front each year and prorated for first and last year of employment.
• 12 company paid holidays
• 7 days of sick time
• 100% employer-paid life insurance up to at 1x annual salary, up to one hundred thousand dollars
• 100% employer-paid short- and long-Term disability coverage
• 401(k) with immediate eligibility and company match
• Partially paid parental leave for eligible employees.
• Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, as well as identity theft protection and pet insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 251-500 employees