Manager, Clinical Quality Assurance
We have an opportunity for a 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 dynamic team, you would be working with a variety of our clients on a range of bespoke project engagements. You will form an integral part of G&L’s QA team – supporting clients and colleagues alike, to ensure that all projects are delivered and expectations are surpassed. All G&L colleagues are expected to be hands-on and tactical in their approach – we are looking for someone who enjoys being involved in the thick of things and rolling up their sleeves!
The Manager, Clinical Quality Assurance is responsible for all quality duties to support clients, agency and client inspections, Standard Operating Procedures etc. The role also ensures adherence to current GCP.
The primary responsibilities of this role include:
- Priotizing and completing multiple projects within established time frames;
- Managing client projects, including managing client relationships and project budgets;
- Preparing for and assisting in clinical site audits and inspections;
- Assisting in the development of operational strategies to ensure the creation of flexible policies and procedures related to clinical research oversight and compliance, with a focus on efficiency and speed;
- Assisting in efforts to include adequate quality elements into each study plan provided by the CRO partner to ensure adequate quality oversight;
- Partnering cross functionally with Clinical Operation and CRO subject matter experts to evaluate areas for process improvements;
- Collaborating cross functionally to ensure the implementation of required procedures, best practices and adherence regulatory requirements, and GCP guidelines;
- Liaising with Clinical Development, CRO, and Clinical sites to conduct and support GCP audit and inspection activities, and maintain a state of ongoing inspection readiness;
The ideal candidate would have:
- Good knowledge of FDA / global clinical trial regulations and ICH E6(R2) GCP Guidelines);
- Understanding of the clinical development process and documentation requirements;
- Proactive approach to GCP compliance
- Knowledge of outsourced models of clinical research conduct and associated sponsor requirements;
- Knowledge of site and vendor auditing processes and recent FDA and EMA compliance landscape;
Our team of consultants are expected to be ambassadors for G&L. 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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