Overview
Clinical Data Quality Associate Jobs in San Antonio, TX at ICON Plc
Location: Houston, TX (Onsite)
Department: Quality Assurance
Reports to: Head of Quality Assurance
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
Foster, lead and embed a strong culture of Quality throughout the organization.
Perform activities to ensure compliance with quality systems, quality procedures, quality policies and applicable regulatory requirements.
Provide guidance and direct activities to ensure manufacturing facility and support areas comply to applicable regulations and industry best standards.
Develop and implement best practice quality improvement programs, policies, procedures and processes.
Manage and oversee the supplier quality management program.
Serve as the quality lead in risk assessments, supporting the identification of quality risks and appropriate mitigation plans to achieve compliant solutions.
Lead and participate in projects within the organizations objectives and project timelines and participate in cross-functional projects as the quality subject matter expert.
Collaborate with other leaders across the organization and assist in the continuous improvement.
Lead and support GMP readiness activities for new programs.
Represent quality assurance at various project and technical meetings, as needed.
Monitor key quality indicators to identify potential risks and for supporting continuous improvement.
Lead and host inspections for customer and regulatory agencies.
Coordinate and assist the development of inspection and internal audit responses.
Prepare and present periodic management updates on Department activities to Leadership.
Other duties as assigned.
Qualifications/Skills
Bachelor’s degree or Associate degree with equivalent work experience.
12+ yrs. related experience in manufacturing processes, QA, Operational Excellence and Training combined.
Understanding of Cell and Gene Therapies.
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
The incumbent in this position works in an office and clean room environment. The incumbent in this position will use the following equipment and shall have the following physical demands:
Equipment-
Computer
Printer
Facsimile
Telephone
Manufacturing equipment
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.
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Title: Clinical Data Quality Associate
Company: ICON Plc
Location: San Antonio, TX
