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Associate Director, Quality Assurance and Regulatory Complia

Company: Trillium Therapeutics Inc.
Location: Cambridge
Posted on: February 17, 2021

Job Description:

Home / Career / Associate Director, Quality Assurance and Regulatory Compliance Associate Director, Quality Assurance and Regulatory Compliance Summary Trillium Therapeutics is a clinical stage immuno-oncology company based in Cambridge, MA and Toronto, ON. Following recent promising clinical data updates and after raising over $300 million in 2020, the Company is now embarking on a substantial organizational scale-up to initiate a phase 2 program across a range of cancer indications. The Company is seeking an Associate Director, Quality Assurance and Regulatory Compliance, to support and lead the continued growth and development of the Company's quality systems in a stage appropriate manner in support of the advancement of Trillium's Clinical Development and Drug Development programs. The position will report into the Sr. Director Quality, Regulatory Compliance & Operations (or similar) and will be based in Mississauga, ON. The Company Trillium Therapeutics (Nasdaq:TRIL) is a clinical stage biotechnology company developing next generation immunotherapies targeting CD47, a checkpoint of the innate immune system. Immunotherapy is a rapidly evolving field that is redefining cancer care by harnessing a patient's own immune system to eliminate tumor cells. First generation immunotherapies, targeting the adaptive immune system via T cell checkpoint inhibitors, have been enormously successful scientifically (2018 Nobel prize), clinically (achieving real cure rates), and commercially (soon to be the largest drug class ever). CD47 is now emerging as one of the most promising next generation immuno-oncology targets. Trillium has two highly differentiated CD47 blockers in development that - unlike other CD47 agents - have shown unique monotherapy activity across a range of hematologic malignancies. Under new leadership, Trillium has undergone a wide-ranging transformation program, including a major strategy reset. In 2020, the company raised over $300M, landed a strategic investment from Pfizer, and has been among the top performers on Nasdaq. Nearing completion of ongoing dose escalation studies, Trillium is now scaling up its organization to initiate a broad phase 2 program across several cancer indications. The Position The Associate Director will support and lead the continued growth and development of Trillium's Quality Management System in a stage appropriate manner in support of the advancement of Trillium's Clinical Development and Drug Development programs. The Associate Director will support the advancement of Trillium's quality management systems and regulatory compliance in key areas including drug development (CMC) and clinical development, working closely with key stakeholders across the organization. The position is based in Mississauga, ON. Accountabilities

  • Oversee and support the implementation of internal stage appropriate Quality Systems across multiple functional areas including but not limited to implementation and lifecycle management of Standard Operating Procedures (SOPs), work instructions (WI), and/or policies as applicable, electronic document management system, electronic learning and training management systems.
  • Oversee vendor qualification, vendor management and vendor GxP audit activities to ensure all outsourced activities supporting clinical development and drug development (CMC) programs and program level deliverables are conducted in compliance with current applicable regulatory guidelines. This may include supporting internal or external GcLP, GCP, or GMP audits (remote or onsite as applicable) either as a lead auditor or co-auditor, working closely with Quality Consultants as required to support these activities.
  • Lead, implement and oversee effective processes for managing Trillium's internal GxP training and qualification programs.
  • Support cross-functional operational groups as a SME in quality and regulatory compliance assisting in implementation of appropriate vendor /project oversight and risk management.
  • Support the development of quality and regulatory compliance processes across all functional areas, working closely with key stakeholders, in support of global expansion of clinical development programs.
  • Develop and implement retention and archival processes in compliance with regulatory requirements, working closely with internal IT, and internal cross-functional leads.
  • Other duties as required and assigned. Qualifications
    • Bachelors of Science degree or higher in Biological Science, Chemistry or related technical discipline.
    • Minimum of 10 years pharma/biotech experience in quality assurance/global regulatory compliance environment in various capacities including inspection readiness, development of risk mitigation strategies and GxP audit experience.
    • Ability to collaboratively engaging with external 3rd parties to effectively and efficiently execute audits (i.e. FDA, Health Canada, EMA) and implement inspection readiness strategies internally.
    • Experience with FDA, Health Canada and EMA at different stages of clinical development encompassing review, approval and post-approval activities.
    • Strong working knowledge and interpretation of FDA, Health Canada, EU, and ICH GxP regulations and guidelines.
    • Strong communication skills both verbal and written, and excellent interpersonal skills.
    • Highly proficient in MS Office Suite (Word, Excel, PowerPoint, MS Project). Personal Attributes
      • Strong values-driven individual who can leverage values to lead and motivate a diverse, cross-regional team.
      • Strong interpersonal, communication, organizational skills and ability to influence.
      • Must be willing and able to be "hands-on", have high attention to detail, and can thrive in a matrixed, fast-paced business environment.
      • Ability to work effectively with other company leaders and develop strong working relationships with them.
      • Willingness and ability to occasionally travel for audits and to the Company's Cambridge, MA office as required. How to Apply Please send your resume and cover letter to with the title of the role in the subject line. Kindly note that phone calls and third parties are not accepted. We thank all applicants for their interest. We will be reaching out only to candidates whose backgrounds most closely match our needs. Cambridge Office 2488 Dunwin Drive
        Mississauga, ON L5L 1J9
        Tel: +1 416.595.0627

Keywords: Trillium Therapeutics Inc., Cambridge , Associate Director, Quality Assurance and Regulatory Complia, Executive , Cambridge, Massachusetts

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