Manager, Quality Assurance Operations
About The Position
Cell Therapy Manufacturing Center (CTMC), a joint venture between National Resilience Inc. and MD Anderson Cancer Center, is a first of its kind biotech located in the world-renowned Texas Medical Center. This unique venture brings together world-class academic cancer research, state-of-the-art cell therapy manufacturing technology platforms, and leaders in clinical cancer care to enable rapid advancement of novel therapeutics from concept to clinic and thereby increase patient access to life saving medicines. CTMC aims to eliminate the bottlenecks that have hampered cell therapy advancement with a multidisciplinary team of dedicated researchers, physicians, drug developers and scientific experts who work collaboratively to develop novel first-in-class therapeutics in an industrial manner within the innovative environment of an academic cancer center. We work in a fast-paced, milestone-driven environment with a focus on team science and interdisciplinary research. Our unique business model has created a biotech-like engine within the walls of the nation's leading cancer center to bring life-saving medicines to our patients more quickly and effectively.
Requirements
- Bachelor's degree in a scientific discipline (Biology, Chemistry, Biochemistry, Biotechnology, or related field) required.
- Minimum of 5–7 years of Quality Assurance experience in a regulated pharmaceutical, biotechnology, or cell and gene therapy environment
- Demonstrated leadership abilities with experience coaching, mentoring, and developing team members.
- Experience supporting Quality Assurance activities within manufacturing, quality control, and/or quality systems operations.
- Working knowledge of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and other applicable GxP regulations.
- Familiarity with applicable regulatory requirements, industry guidance documents, and quality standards.
- Effective interpersonal skills with the ability to collaborate across cross-functional teams.
- Excellent organizational skills and attention to detail.
- Ability to prioritize multiple tasks and manage competing deadlines in a fast-paced environment.
- Strong verbal and written communication skills.
- Strong analytical and problem-solving skills.
- Proficiency with Microsoft Office Suite and quality management systems (e.g., electronic document management systems, deviation and change control systems).
Nice To Haves
- 1–3 years of supervisory or management experience preferred.
- Basic understanding of Cell and Gene Therapy manufacturing processes and quality systems preferred.
Responsibilities
- Serve as a Quality Operations leader providing quality oversight and support for GMP manufacturing operations, ensuring compliance with regulatory requirements, company procedures, and quality standards.
- Perform and approve batch disposition decisions for raw materials, intermediates, and drug products, ensuring timely and compliant product release.
- Lead comprehensive review and approval of batch production records, laboratory records, and associated GMP documentation to ensure accuracy, completeness, and adherence to cGMP requirements.
- Manage quality records including deviations, CAPAs, change controls, investigations, and other quality system records, ensuring timely closure and effective resolution.
- Provide quality oversight of aseptic manufacturing operations, ensuring adherence to contamination control strategies, aseptic techniques, and GMP behaviors.
- Partner closely with Manufacturing, Quality Control, Supply Chain, Validation, and Technical Operations to proactively identify and resolve quality and compliance issues.
- Participate in quality review boards and cross-functional governance meetings, providing risk-based recommendations and quality leadership.
- Author, review, revise, and approve SOPs, work instructions, specifications, and quality system documents.
- Support inspection readiness activities and participate in regulatory inspections, customer audits, and internal audits.
- Drive continuous improvement initiatives focused on compliance, efficiency, quality metrics, and operational excellence.
- Support onboarding, training, mentoring, and development of Quality Operations team members.
- Perform other duties and responsibilities as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
