Assoc Director, QA

Job Type: Officer of Administration Bargaining Unit: Regular/Temporary: Regular End Date if Temporary: Hours Per Week: 35 Standard Work Schedule: Building: Salary Range: $175,000 - $200,000 The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. Position Summary The Associate Director of Quality Assurance (QA) for the CICET facilities is responsible for upholding the highest standards of quality and safety in the production of cell and gene therapeutics in the cGMP laboratory at Columbia University Irving Medical Center. This role is critical in ensuring adherence to all regulatory requirements and safety protocols for both sponsored and investigator-initiated clinical trials. The QA Associate Director will be charged with the development, process improvement and oversight of the quality and safety of the production facility. The Associate Director will provide strategic and operational leadership for the QA function. This position will report to the Director of CICET Core Facilities and work closely with the Associate Director of QC and Analytics with regards to operational and bioinformatics data analyses. Responsibilities Quality Assurance Program Development Develop and maintain a comprehensive QA program that meets FDA, GMP, FACT, and other regulatory requirements for advanced therapy medicinal products. Develop and implement QA systems and processes to ensure compliance with cGMP, FDA, and other regulatory standards. Develop, author, review, and/or approve protocols, Standard Operating Procedures (SOPs), specifications, regulatory filings, and other controlled documents. Compliance and Regulatory Affairs Ensure that all manufacturing processes comply with FDA, GMP, FACT, and other regulatory standards. Lead the preparation and management of internal and external audits, including FDA inspections. Serve as the primary point of contact for regulatory audits and inspections, coordinating with associated parties, sponsors, and stakeholders. Support and/or coordinate internal and external regulatory audits as required. Monitor and report on quality metrics and performance indicators. Oversight and Management Provide QA oversight for all cell and gene therapy projects, ensuring that all products meet quality standards and regulatory requirements. Establish and oversee environmental monitoring programs of the GMP facility to ensure conditions meet ISO and GMP standards, including cleaning procedures and monitoring trends. Develop and operationalize quality management systems for the cGMP facilities for incoming materials, in-process samples, and finished products. Oversee the development, implementation, and maintenance of quality systems, including document control, CAPA plans, change control, and training programs. Manage deviations, incidents, and out-of-specification investigations, including corrective and preventive action (CAPA) plans. Team Leadership and Collaboration Actively manage QA personnel, overseeing performance, mentoring, and career development. Collaborate with Manufacturing Operations, QC/Analytics, and Regulatory Affairs teams to ensure quality throughout the product lifecycle. Work closely with other functional areas to develop and execute against the strategic plan for CICET facilities. Establish and maintain key relationships with internal and external stakeholders. Continuous Improvement and Industry Engagement Monitor and report on quality metrics and performance indicators. Stay current with industry trends and regulatory updates related to cell and gene therapy QA. Work on complex problems requiring in-depth evaluation of various factors, exercising strong judgment in resolving issues and making high-impact recommendations. Minimum Qualifications Educational Requirements Bachelor's degree in Biology, Chemistry, or a related scientific field, or equivalent in education and experience Professional Experience At least 4 years of experience in QA within a GMP-regulated environment Proven track record of successful FDA or other regulatory audits Technical and Knowledge Expertise Knowledge of environmental monitoring practices and cleanroom operations Working knowledge of computer programs such as Microsoft Outlook, Word, Excel, PowerPoint, SharePoint, Teams, Adobe Acrobat, and Zoom Skills and Abilities Excellent organizational skills and ability to manage multiple priorities Strong interpersonal and communication skills (written/verbal) Ability to set priorities and exercise sound judgment and initiative Capability to handle multiple projects simultaneously and prioritize tasks while ensuring timely execution Interpersonal and Customer Service Skills Strong customer service orientation and skills, with the ability to interact and collaborate positively, constructively, and effectively with multiple constituencies Preferred Qualifications Strongly prefer at least 7 years of experience in QA within a GMP-regulated environment Advanced degree in a relevant scientific discipline Certification in Quality Management Systems (e.g., CQM, CQA) Experience with cell and gene therapy products Strong analytical and problem-solving skills, with a detail-oriented approach Other Requirements Successful completion of applicable compliance and systems training requirements Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents.

Created: 2024-11-19