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Director, Quality Assurance

Company: WTS International
Location: Rockville
Posted on: February 25, 2021

Job Description:

Attachments: Please include your resume and up to two additional documents. Add File 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 Required Education and Experience
    • BS or equivalent in life science with 8-10 years industry experience in Quality Assurance for a pharmaceutical, biotech, and/or cell therapy/gene therapy company, or equivalent training and experience. Master's degree in life science preferred
    • Demonstrated success in making informed decisions for the department
    • The ability to prioritize and handle multiple activities on a daily basis yet flexible and responsive to frequently shifting priorities
    • Demonstrated ability to integrate into a team environment with a positive attitude
    • Strong written and verbal communication skills are required
    • Demonstrated ability to accomplish stated goals through others even though they may not report directly to you
    • Strong sense of ethics and honesty
    • Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products required Internal Number: 2020 RA001 About Immunomic Therapeutics, Inc. Immunomic Therapeutics, Inc. (ITI) is a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms. These investigational technologies have the potential to alter how we use immunotherapy for cancer, allergies and animal health.By investing over $60M early in 2020, HLB Co., LTD, a global pharmaceutical company focused on developing novel cancer drugs, ITI is well-positioned to accelerate its immuno-oncology platform, in particular glioblastoma multiforme, and rapidly advance other key candidates in our pipeline, including the most recent initiative into infectious diseases with development of its vaccine candidate for COVID-19.All program areas are driven by ITI's UNITE--- platform.

Keywords: WTS International, Rockville , Resources
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