Sr. Manager, Quality Assurance QMS & Shared Services chez CTMC

Location: (Onsite) Houston, TX
Department: Quality Assurance
Reports to: Associate Director, Quality Service

About CTMC 

CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, located in the heart of the Texas Medical Center. Our mission is to accelerate cell therapies from bench to bedside. We offer a wide range of cell therapy modalities, including CAR-T, TIL, and TCR-T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients. 

Since inception in May 2022, our team has filed eight INDs and have received approval, without delay, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results. 

Our growing, state-of-the-art, 60,000 sq. ft. industrial facility in the Texas Medical Center is staffed by an integrated team of industry veterans and academic scientists who are passionate about bringing life-saving cures to patients. Our unique joint venture structure, with two highly established partners, provides us with the financial stability and long-term horizon to achieve our organizational goals. 

At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure to inspire professional growth and satisfaction. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission to accelerate cell therapies from bench to bedside for patients who need them. If you share our passion for advancing the frontiers of medical science with innovative therapeutics and want to join a highly dedicated team committed to delivering novel cures to patients, we invite you to submit your application. We look forward to hearing from you and exploring how your skills and expertise can help us achieve our mission.

Responsibilities

• Manages and oversees the change control, deviation, CAPA and effectiveness check systems/programs.
• Provides QMS leadership during eQMS development/improvement programs and/or projects involving department and cross-functional teams.
• Provides KPI’s/KQI’s for all QMS programs. 
• Manages and oversees the Quality validation program (Installation and Operational Qualifications protocols and reports, discrepancies), calibration and maintenance records.
• Assesses and approves change control proposals and implementations.
• Evaluates and approve quality records.
• Develops and delivers quality training to site.
• Supports regulatory and clint audits as subject matter expert for validation and QMS.
• Prepares and present periodic management updates on Department activities to Leadership.
• Creates and manages the document control system (DCS), ensuring all documents are properly cataloged, indexed, and accessible
• Identifies and reports document-related non-conformances and lead or support corrective and preventive actions (CAPAs).
• Leads and participates in special projects related to quality systems and documentation. 
• Other duties as assigned. 

Qualifications/Skills 

• Bachelor of Science in Engineering, Quality Management, Management, or related science discipline. 
• 12+ yrs. related experience in manufacturing processes, QA, Operational Excellence and Training combined or equivalent combination of education and experience.
• Understanding of Cell and Gene Therapies. 
• Comprehensive knowledge of validation lifecycle for aseptic processing, equipment/facility/utility validation.
• Experience with Veeva QMS preferred.
• Experience with Health Authority regulations (US FDA, EMA, ISO 9001, ISO 13485, etc.) preferred.
• Demonstrate expertise in multiple QA related areas; SME in specific areas related to systems. 
• Understanding of cGxPs.
• Knowledge of local and global regulations. 
• Excellent verbal and written communication skills. 
• Excellent interpersonal and customer service skills. 
• Excellent organizational skills and attention to detail. 
• Excellent time management skills with a proven ability to meet deadlines. 
• Strong analytical and problem-solving skills. 
• Proficient with Microsoft Office Suite or related software. 

Working Conditions, Equipment, Physical Demands 

Physical Demands-  

• Frequent standing, walking, sitting, and reaching required.
• Frequent lifting up to 10 lbs. required.
• Occasional lifting, pushing, and pulling up to 50 lbs. required.
• Frequent use of computer/keyboard required.

The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act. 

The above job description is an overview of the functions and requirements for this position. This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.