Job Description

Immunomic Therapeutics, Inc., a growing Pre-IPO clinical stage biotechnology company is seeking an innovative and highly motivated Director, Quality Assurance to join our expanding team. This position reports to the Vice President, Regulatory Affairs and is responsible for providing quality oversight of CMOs and CROs providing manufacturing and clinical trial services.  The Director will maintain and improve the Quality Management System (QMS) through continuous development, implementation and maintenance of quality standards, policies and procedures incorporating phase-based flexibility that ensure rigorous regulatory compliance.  Additionally, the Director, Quality Assurance will be responsible for establishing a scalable quality system to support the future establishment of internal cGMP manufacturing capabilities.

Essential Functions

• ITI Quality Management Systems, including building a team to support the company’s growth
• Routine systems, procedures, and records to support cGMP-compliant manufacturing and participate in Quality Management activities such as CMO, CRO Quality Agreement, Vendor qualification, Deviations, CAPA, and Change Control
• Quality Document Control Management system and establish a Training program.
• Initiation and approval of quality investigations, assessments, and reviews or evaluations of quality events such as deviations, CAPA, change records, etc. and recommend corrective actions/CAPAs related to cGMP and GCP issues
• Timely review of batch records and analytical records for approval of investigational products
• Monitoring, reviewing and assessment of ongoing stability test results
• Provide Quality Assurance oversight and support activities including Quality System infrastructure, for the new cGMP facility build out
• Proactively identify compliance issues/risks, within the organization and with external partners
• Partnership approach with Project Teams and individual Departmental staff to provide guidance and strong Quality leadership
• Demonstrated experience building and leading exceptional Quality Assurance and Quality Systems teams
• Responsible for hiring and managing Quality Assurance staff.  Will be responsible for overseeing any Quality consultants and managing other related vendors.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Please visit our careers site at http://www.immunomix.com/careers/.  Send your cover letter and credentials as described on the Careers page along with the Job Code: 2020 RA001 in the subject line.

Equal Opportunity Employer