Immatics · 7 hours ago
Senior Quality Assurance Investigations Specialist - Second Shift
Houston
Full-time
Onsite
Senior Level
5+ years expImmatics is committed to making a meaningful impact on the lives of patients with cancer. They are seeking a Senior Quality Assurance Investigations Specialist to oversee quality events for the batch release process for cell and gene therapy products, ensuring compliance with regulatory requirements and driving process improvements.
Biotechnology
Responsibilities
Independently author/review deviations in order to meet Batch release requirements for cell and gene therapy product
Focus on deviation closeout and providing resolution by ensuring timely identification, investigation, and closure of deviations, including root cause analysis and implementation of effective corrective and preventive actions (CAPA)
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
Communicate 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
Utilize advanced root cause analysis techniques and technical impact analyses during the deviation investigation process
Manage multiple priorities either independently or as part of a team in order to meet key deadlines and communicate issues and progress across all levels of the organization
Participate in internal and external audits, inspections, and regulatory submissions, providing necessary documentation and information
Provide guidance and support to junior members of the quality assurance team, including training, mentoring, and performance evaluation
Participate in the training process and coaching of new team members and processes
Assist with metric reporting and workload management to meet the team’s priorities
Maintain and update batch release procedures, protocols, and documentation in accordance with current regulatory guidelines and industry best practices
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
Qualification
Required
Bachelor's degree in pharmaceutical sciences, life sciences, bioengineering, or a related field
Experience (5+ years) in quality assurance, preferably within the cell and gene therapy industry, or biopharma with a focus in batch release and Deviation writing and approval
At least 6+ 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
Preferred
Master's degree or higher preferred
Benefits
Competitive rates for Health, Dental, and Vision Insurance
4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment.
Sick Time Off – 56 hours
12 Paid Holidays
100% Employer-Paid Life Insurance up to at 1x annual salary, up to 100K ( club together)
100% Employer Paid Short- and Long-Term Disability Coverage
401(k) with Immediate Eligibility & company match…
You are eligible for 401(k) plan participation as of your first paycheck.
The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.
Partially paid Parental Leave for eligible employees. (3 weeks)
Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance.
Company
Immatics
Immatics is committed to making a meaningful impact on the lives of patients with cancer.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Steffen Walter
Chief Operating Officer
Recent News
2025-10-03
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2025-09-09
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