Associate Director, Quality Assurance Operations

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 six 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, an ambitious biomanufacturing organization that has raised $2 billion in two years, 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 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:

• Ensure line-clearance/ change-over activities are executed.
• Oversee the disposition, hold, or rejection of raw materials, starting materials, in-house prepared materials, intermediates, and drug products.

• Ensure the generation and reconciliation of in-process and Drug Product labels is performed with compliance aspects being met.
• Ensure the review and approval of executed documents related to manufacturing operations, QC, and other departments is performed with compliance aspects being met.
• Initiate, author, review and approve deviations, CAPAs and Change Controls associated with Quality Operations practices as well as other departments.
• Create, review, and approve procedures and practices within Quality Operations to implement company quality standards.
• Partner with other departments to implement, optimize, review, and approve batch records, practices, and procedures.
• Accomplish quality assurance objectives by monitoring, reviewing, and enforcing policies and procedures.
• Develop quality assurance plans by conducting hazard analyses and monitoring procedures.
• Achieve quality assurance operational objectives by contributing to information analysis.
• Validate quality processes by establishing product specifications and quality attributes.
• Maintain and improve product quality by completing product, company, system, and compliance audits.
• Train and motivate employees on Quality Operations procedures and practices to ensure quality standards are met.
• Lead and manage a team of quality professionals, directing them toward achieving goal-oriented tasks.
• Support the recruitment process by assisting in the identification, selection, and hiring of qualified candidates.
• Other duties as required.

Qualifications/Skills

• Bachelor’s degree in a scientific field.
• 12 yrs. related experience in QA.
• 6 yrs. managerial experience, preferably within QA.
• Understanding of Cell and Gene Therapies.
• Demonstrate expertise in multiple QA related areas; SME in specific areas related to operations.
• Understanding of cGMPs, GLPs and GXPs.
• 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.
• Strong supervisory and leadership skills.
• Proficient with Microsoft Office Suite or related software.

Working Conditions, Equipment, Physical Demands

The incumbent in this position works in an office environment. The incumbent in this position will use the following equipment and shall have the following physical demands:

Equipment- Computer, printer, fax, and telephone.

Physical Demands- Prolonged periods of sitting at a desk and working on a computer and must be able to lift up to 15 pounds at times. In addition, ability to sterile-gown and perform activities in the manufacturing suite as well as raw material area when applicable.

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.