What are the responsibilities and job description for the Associate Director, Quality Assurance Operations position at CTMC?
Job Description
Job Description
About CTMC
CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, and located in the renowned 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, ETC, and TCR-T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients.
In our first year alone, we have filed 8 INDs, each ahead of schedule, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience leverages their experience in advanced technology and processes to deliver exceptional results.
Our state-of-the-art, 60,000 sq. ft. facility in the Texas Medical Center is staffed by an integrated team of industry veterans and 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 mission.
At CTMC, we value our employees and offer a variety of development opportunities within our organization. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission. 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
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.
