Job Details

Summary

About Us:

Eupraxia Pharmaceuticals Inc. is a publicly owned novel pharmaceutical company based in Victoria, British Columbia. We are drug delivery company that focusses on delivering the right therapeutics to the right area in the right dose to improve patient lives. Our lead product candidate is an extended-release steroid intended to provide long term pain relief for patients suffering with knee osteoarthritis and we are actively expanding our portfolio of products.

We are looking for people that like to be part of a fast-paced, growing company that fosters creative spirit and integrated teamwork.

Location:  Flexible but must be in North America, able to work PST hours.  Head Office  in Victoria, BC

Job Description:

This role will provide the overall leadership in Quality to ensure Internal conformance to policies and standards, provide procedural QA excellence for Supply Chain, Clinical and Regulatory as well as adequate implementation of quality standards for regulated IT systems. They will oversee all Quality compliance training programs and provide corporate leadership in delivering Inspection Readiness (GXP related).

 

Reports to:  CSO

Responsibilities:

Quality Leadership

  • Strategic direction of the Quality Department
  • Management of QA staff, vendors and consultants
  • Implementation of Quality Plans that reflect and support corporate goals
  • Participation in the development of Manufacturing, IT, Clinical and Regulatory strategies and systems

Quality Assurance

  • Establish and coordinate the QA Audit Program (trial sites, CRO and related vendors, CDMO vendors and Trial Master Files) and the QA review of clinical study documents.
  • Provide leadership as a quality expert in GCP/GMP compliance to groups within Eupraxia  
  • Ensure Eupraxia QA, Manufacturing, Clinical and Regulatory (including suppliers and strategic partners) are “inspections ready”
  • Ensure the maintenance of corrective actions and preventive actions (CAPA) system for CQA, Clinical and Regulatory in collaboration with other QA functions
  • Track expenditures against budget and plan for future budgets
  • Maintain a current working knowledge of applicable regulations and industry guidance

Internal Compliance

  • Oversee the execution of internal risk-based audits program for Manufacturing, Clinical, Regulatory and regulated IT Systems to ensure continued compliance with global GCP and electronic systems requirements (e.g. GAMP, validation, disaster recovery, back-up, securities, e-signatures, etc.); and with established company policies and guidelines

Training

  • Develop and implement annual GCP and relevant regulatory requirements training
  • Assist Clinical and Regulatory in embedding compliance-related principles in their ongoing functional area training

Information Technology

  • Ensure proper implementation (i.e. to appropriate quality standards) for regulated IT systems that impact Supply Chain, Medical Affairs, Clinical and Regulatory departments
  • Provide leadership in the delivery of quality guidance and advice with particular expertise in computer system validation within Eupraxia

Change Control Management

  • Ensures corporate objectives and industry practices are incorporated into QA, Manufacturing, Clinical and Regulatory policies and SOPs
  • Contribute in and/or Lead the Global Quality System for procedurals documents review, maintenance and approval (i.e. change control)
  • Develop, implement and maintain CQA procedural documents
  • Participate in overall process improvement

Requirements:

  • A higher degree is required in a discipline relevant to the Pharma Industry
  • 5 – 10 years regulatory experience, in a series or more demanding Quality roles.
  • A background ideally in specialist drug development.
  • A solid track record of delivery
  • Leadership experience, proven ability to influence at executive and Board level and with key regulators
  • Outstanding written and oral communication skills
  • A logical, data rational and articulate individual.
  • Able to work in a highly networked organization with many partners both internal and external
  • Ability to travel internationally.
  • Attitude and behavior should be congruent with the start-up / SME situation of Eupraxia, e.g.
    • Sets a positive image/impression
    • Is flexible and yet results oriented
    • Shows concern for standards and is thorough and detail conscious
    • Can think and influence conceptually, strategically, and rationally.
    • Interpersonally aware and culturally sensitive.
  • Energetic and enthusiastic, with the drive and determination to set standards, improve quality at every level and the business acumen to manage complex issues and environments

This is an opportunity to work in a small, entrepreneurial, and highly motivating environment, with a strong emphasis on work/life balance and a supportive company culture. We offer a competitive salary, excellent benefits, and career development opportunities.

How to Apply:

  • Please send your CV and cover letter to careers@eupraxiapharma.com .
  • While only short-listed candidates will be notified, we thank each applicant for their submission.