Role overview

About Us:

Eupraxia is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. DiffuSphere, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support an extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians want to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the DiffuSphere technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia's DiffuSphere technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas extend beyond pain and inflammatory gastrointestinal disease, where Eupraxia is currently developing advanced treatments, to applications in oncology, infectious disease and other critical disease areas.

Eupraxia's EP-104GI is currently in a Phase 1b/2 trial (RESOLVE) for the treatment of eosinophilic esophagitis (EoE). EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also recently completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The SPRINGBOARD trial successfully met its primary endpoint and three of the four secondary endpoints. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com.

We are looking for people who would like to work for a fast-paced, growing company that fosters a creative spirit and integrated teamwork and who are eligible to work in Canada.

Scope

The QA Manager is responsible for ensuring investigational medicinal products (IMPs) meet current Good Manufacturing Practices (cGMP). This role serves as a quality partner to internal teams, executing hands-on batch reviews, investigations, vendor management and compliance oversight while seamlessly bridging the gap between technical, clinical, and regulatory operations.

Reports to: Senior Director, Quality Assurance

Key responsibilities and duties:

Ensure procedures and systems are established and maintained to ensure the Company’s compliance with ICH GXP guidelines; current national and international legislation; and relevant regulations, standards and guidelines
Spearhead continuous quality improvement activities
Oversee the implementation, manage the content, coordination, and execution of the Eupraxia electronic Quality Management System (eQMS).
Define and manage the delivery of training programmes for employees via the eQMS
Coordinate external audits, internal audits and gap analyses
Manage the QA oversight of contract manufacturers and testing labs (internal/external) to ensure products/deliverables meet all required quality standards and specifications.
Perform rapid and agile record review and disposition activities for clinical trial material including manufacturing, testing and labelling/packaging batch records
Lead extensive investigations with vendors and interdepartmental teams to determine product quality impact and resolve potential product quality issues.
Act as the single point of QA contact with vendors, contract facilities and joint development collaborators for contracts, validation activities, change management and other QA issues
Drive the implementation of other quality systems, including departmental and corporate procedures, to ensure compliance with GXPs.
Review CMC documents submitted to regulatory agencies.
Develop work instructions and/or standard operating procedures
Lead inspection readiness preparation and training
Review and approve new procedures, specifications, analytical methods and other quality documentation as required
Collaborate cross-functionally to ensure the implementation of required procedures, best practices and adherence to regulatory requirements and GCP guidelines
Negotiate and maintain Quality Agreements with GXP service providers
Build and maintain strong working relationships with members of the CMC, Regulatory Clinical Operations and Supply Chain teams

Education, qualifications and work experience:

B.S. in a science related discipline (preferably in chemistry, biochemistry, or chemical engineering)
8+ years related experience in the biotechnology or pharma industry with a sound knowledge and focus on GMP operations, process development/technology transfer validation/ manufacturing/testing/ CMC or equivalent combination of education and experience
Knowledge of GCP and experience with clinical operations would be an asset
Demonstrated experience with eQMS Tools, Gantt Charts, Excel Spreadsheets and Project Planning tools, Smartsheet
Experience in planning, organizing and conducting audits.
Experience in preparing for inspections ideal
Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met.
Critical thinker, outgoing and enthusiastic and well-organized.
Excellent written, spoken, listening and presentation skills and a demonstrated ability to influence within the wider project team at the level of functional leadership.
Self-motivated; able to work independently and within a team
Excellent time management and multi-tasking skills
Maintains a composed, collaborative and independent manner when dealing with issues, challenges, conflicts and opportunities.

Salary Range: $95,000 to $130,000, depending on education and relevant experience

While only short-listed candidates will be notified, we thank each applicant for their submission.