Director, Clinical Quality Assurance
We have an opportunity for a senior 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 working closely with key stakeholders to design and implement bespoke solutions to their requirements. You will also form an integral part of the 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 Director of Clinical Quality Assurance is responsible for the Clinical oversight and conduct of activities for their GCP activities and direct reports, if assigned. The role also ensures adherence to current GCP and participates in activities as required.
Your duties may include:
- Serve as subject matter expert concerning GCP and provide compliance guidance to internal personnel within Clinical and Quality departments;
- Establish efficient vendor and site oversight operations to ensure a continuous awareness of the state of compliance for each study;
- Lead 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;
- Lead efforts to include quality elements into each study plan provided by the CRO partner to ensure adequate quality oversight;
- Partner cross-functionally with Clinical Operation and CRO subject matter experts to evaluate areas for process improvements;
- Collaborate cross-functionally to ensure the implementation of required procedures, best practices and adherence to regulatory requirements and GCP guidelines;
- Develop and deliver relevant training to Clinical Development staff, for example annual GCP training, SOP training, etc.;
- Manage strategic/compliance risk assessments, evaluate metric reporting, and facilitate root cause analysis and CAPA process implementation and effectiveness checks;
- Liaise with Clinical Development, CRO, and Clinical sites to conduct and support GCP audit and inspection activities, and maintain a state of ongoing inspection readiness;
- Mentor and manage staff, contractors, and/or consultants;
- Ensure Clinical Study departments have annual GCP training.
You may also be asked to:
- Speak at conferences and webinars, as appropriate;
- Present learnings to internal team.
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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