Associate Director, Quality Assurance and Regulatory Complia
Company: Trillium Therapeutics Inc.
Posted on: February 17, 2021
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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
- 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
- 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
- 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
- Experience with FDA, Health Canada and EMA at different stages
of clinical development encompassing review, approval and
- 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
- 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
email@example.com 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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