QMS & Shared Services, Supervisor at Resilience Texas LLC

Houston, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Jul, 26

Salary

0.0

Posted On

03 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management Systems, GMP Auditing, Change Control, CAPA, Supplier Quality Management, Cell and Gene Therapies, Regulatory Compliance, Veeva QMS, Internal Auditing, Document Control, Risk Assessment, RCA, FMEA, Quality Training, Validation, Biotechnology

Industry

Biotechnology Research

Description

Position FLSA Status: FT Exempt Location: Houston, TX 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 * Day to day supervision of the change control, deviation, CAPA and effectiveness check systems/programs. * Provide 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. * Plan, schedule, lead, and execute internal and external (supplier/vendor) quality system audits according to established procedures and regulatory requirements. * Maintain and improve audit program, including audit schedules, checklists, and reporting. * Assesses and approves change control proposals and implementations. * Evaluate and approve quality records. * Develops and delivers quality training to site. * Support regulatory and client audits as subject matter expert for validation and QMS. * Prepare and present periodic management updates on Department activities to Leadership. * Create and manage the document control system (DCS), ensuring all documents are properly cataloged, indexed, and accessible * Identify and report document-related non-conformances and lead or support corrective and preventive actions (CAPAs). * Lead and participate in special projects related to quality systems and documentation. * Lead the initial qualification and ongoing re-qualification of critical suppliers, including system assessments, on-site audits, and technical reviews to ensure robust Quality Management Systems (QMS). * Plan, execute, and report on supplier and contractor audits globally, including CMOs, CROs, raw material providers, and service suppliers. * Review and approve supplier-initiated change notifications, assessing their potential impact on product quality and compliance, and ensuring necessary internal actions are taken. * Triage supplier change notifications, assess material/specification changes, and initiate or coordinate change controls as required. * Mentor and train junior quality specialists and cross-functional partners on audit techniques, supplier quality requirements, and use of quality tools (e.g., RCA, FMEA). * Author, review, and approve departmental Standard Operating Procedures (SOPs) and work instructions related to supplier quality and auditing. * Other duties as assigned. Qualifications/Skills * Bachelor’s degree in Life Sciences, Engineering, or related discipline required; advanced degree preferred. * 8+ years of progressive experience in Quality Assurance, supplier quality management, or GMP auditing within the pharmaceutical, biotechnology, or medical device industry. * Understanding of Cell and Gene Therapies. * Certified Quality Auditor (CQA), ISO Lead Auditor, or equivalent certification strongly preferred. * Demonstrated experience hosting and supporting FDA, EMA, MHRA, or other regulatory inspections. * 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 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.

Responsibilities

The supervisor will oversee QMS programs including change control, deviations, CAPA, and supplier quality audits. They will also lead cross-functional quality projects, manage document control systems, and provide leadership during regulatory inspections.