Immatics US, Inc. is a highly innovative biopharmaceutical company based in Houston, TX (USA) created through a partnership of MD Anderson Cancer Center with of Immatics Biotechnologies, headquartered in Germany. Our goal is to deliver adoptive cellular immunotherapies directed against novel cancer targets in indications with highly unmet medical need. Immatics is the globally leading biopharmaceutical company in the development of cancer immunotherpaies based on proprietary pMHC Targets and T-cell Receptors building a broad proprietary clinical pipeline as well as partnered pipelines with leaders in the field such as Amgen, Roche and Genmab.
Immatics US pipeline is based on adoptive cellular therapy (ACT). ACT has demonstrated dramatic clinical effects in melanoma and certain blood cancers. However, relevant and safe targets to translate these initial successes to other so-called solid cancer types are critically lacking to the field. ACT has the potential to induce significant clinical benefits including rapid clinical responses and can potentially be developed up to FDA marketing approval within few years.
Immatics US is based in Life Science Plaza in the Texas Medical Center in Houston (TX) with a significant 25,000 sq.ft. R&D and office infrastructure. Immatics US has a team of approximately sixty highly qualified research, medical and business professionals and we are looking for team members who constantly strive for excellence and whose motivation is driven by their passion for pioneering therapies and scientific innovation. We offer a competitive salary based on experience, and a comprehensive benefits package and a company culture based on people believing in taking responsibility and working together to deliver the best outcomes.
Clinical Quality Assurance Manager
The Clinical Quality Manager is responsible for managing and directing Clinical Quality Assurance (CQA) activities to support Good Clinical Practices (GCP) for all studies in the Immatics portfolio.
- Work directly with internal and external stakeholders to ensure GCP compliance for ongoing and planned clinical trials
- Manage corrective and preventative activities for GCP issues as they arise
- Develop and maintain Clinical Quality systems to support clinical trial activities
- Provide support for internal audits and agency inspections.
- Perform routine compliance checks and/or GCP audits of clinical sites, CROs, and other clinical vendors
- Assists in authoring Clinical Operation’s SOPs and processes as needed
- Develops and supports record retention and archiving procedures
- Provide input for quality process improvements and manage change for CQA systems
- Assists with development and maintenance of relevant documents for the Clinical Quality department
- Develops and maintains CQA SOPs
Qualifications and Skills
To be considered for this position, applicants must meet the following requirements:
- Bachelor’s Degree in science or other relevant field of study.
- 10+ years focused on process improvement, SOP development, quality assessment and management
- 5+ years of quality experience in a GCP-regulated environment
- Demonstrated knowledge of clinical processes and procedures, electronic documentation system, and Good Clinical Practices 21CFR, Parts 50, 56, and 312.
- Demonstrates effectiveness in maintaining CQA control systems for compliance with FDA regulations
- Experience with system validation process, developing user requirements, and performing end user acceptance testing
- Experience developing a Clinical quality program, is preferred
Other Skills and Abilities
- Strong interpersonal skills
- Ability to provide support in a collaborative environment
- Ability to plan and organize work in an efficient manner, work well under time constraints, and achieve project timelines
- Ability to identify resource needs, develop project plan, communicate risk, as well as, a risk mitigation strategy
- Proficiency in Microsoft Suite
TO APPLY, PLEASE FORWARD RESUME TO HR-US@immatics.com