Senior Associate, Clinical Quality Assurance
We have an opportunity for an experienced quality assurance professional to join our team in Canada. We are looking for a dynamic and flexible individual who has a consultative approach to their work. We work with a broad selection of pharmaceutical, biotechnology and device clients across the globe and each project can vary significantly.
As part of our team, you would be supporting clients, colleagues, Standard Operating Procedures, study site management, Trial Master File Management, etc. The role also ensures adherence to GCP and applicable regulatory standards/requirements for clinical trials. Your duties may include the following:
- Prioritizing and completing multiple projects within established time frames
- Assisting with client projects, day-to-day clinical quality activities as assigned
- Participating in agency and client GCP audits
- Assisting with the development of clinical quality standard operating procedures, study plans
- Participating in clinical quality projects to continuously improve processes, tools, and systems
- Assisting with Trial Master File management, review, and maintenance
- Identifying needs, bottlenecks, and deviations within the study team
- Participating in client meetings and teleconferences
- Attending conferences where appropriate
- Maintaining GCP knowledge.
Our ideal candidates would have:
- A life science degree (e.g. BSc, MSc) or equivalent qualification
- A minimum of 1–2 years of relevant experience in a quality role
- Prior experience working with CROs
- Comprehensive experience in Quality including knowledge of current GCP in Canada, US and Europe. Good knowledge of ICH, US and Canadian legislation and regulatory guidance
- Sound written and oral communication skills, good organizational and planning skills, and effective presentation skills to a variety of audiences
- Strong computer skills
- Ability to build positive, production relationships with colleagues and clients
- Advanced level in written English, intermediate level in oral English. Ability to speak and write French is an asset
- May be required to develop new departmental procedures or systems and/or monitor the progress of ongoing department procedures.
Our team of consultants are expected to be ambassadors for G&L. –Working directly with clients and Health Authorities we really value communication skills and the art of negotiation and diplomacy.
All our staff are encouraged to have the confidence to speak their mind and suggest new ideas. All our consultants are expected to act as mentors to junior staff, contributing to the development of graduate and junior training programs.
Above all, our company is all about our people – so you should have a passion for meritocracy, recognition, and development.
We hope that you will feel excited about making suggestions or challenging existing methodologies. G&L’s reputation has been built on our customer service and client-focus so any ideas that will help us stay ahead of the curve are encouraged.
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