Senior Manager, Clinical Quality Assurance
ImmaticsAbout the role
Join Immatics and shape the future of cancer immunotherapy; one patient at a time!
Immatics is at the forefront of immunotherapy innovation, working to harness the power of T cells to transform cancer treatment.
Immatics is an exceptional clinical-stage biopharmaceutical company active in the discovery and development of T cells redirecting cancer immunotherapies. We use these powerful T cells to develop groundbreaking immunotherapies that target cancer cells. We are dedicated to transforming cancer treatment and improving patient outcomes through cutting-edge research and advanced TCR technology.
Why Join Us?
Innovative Environment: Help to pioneer advancements in cancer immunotherapy.
Collaborative Culture: Be part of a diverse team dedicated to your professional growth.
Global Impact: Contribute to therapies that make a lasting impact on patients globally.
We are seeking an Senior Manager CQA, to support our Clinical Quality Assurance (CQA) team. This position implements, maintains, and supports Clinical Quality Assurance (CQA) systems and processes at Immatics, particularly those related to GCP auditing, GCP advice, GCP training, inspection readiness and CQA administration.
FLSA Classification: Salary, Exempt
Schedule: 8:00 AM – 5:00 PM; Monday to Friday
Reports to: Senior Director, CQA
Location: Fully Remote
What You’ll Do:
As an Senior Manager CQA you will play a key role in supporting :
Implement and maintain quality assurance related to Immatics clinical trials (GCP QA function)
Plan, conduct and follow-up clinical trial related audits, e.g. GCP vendor audits, clinical trial site audits, and/or document audits; or support these activities
Plan, conduct and follow-up on and internal audits of GCP relevant Immatics systems and processes
Support the generation of annual audit schedules
Support preparation and hosting of regulatory inspections
Provide support and maintain documentation and oversight of CQA-related change controls, GCP and protocol deviations, related CAPAs, and SOPs
Organize and deliver GCP and quality related training to company personnel
Provide support to clinical functions regarding GCP vendor selection, qualification and oversight
Provide support to clinical functions regarding GCP inspection readiness
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