Regulatory Quality Services Specialist

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

The Regulatory Quality Services Specialist has a supportive role for clients, agency and client inspections, Standard Operating Procedures, quality agreements, product disposition pre and post market. The role also ensures adherence to current GMPs for Pharmaceutical Drugs and Biologics.

Role Responsibility:

• Reviews batch records, supports complaint and deviation processes within the QMS
• Investigates inbound and outbound transit temperature excursions and excursions at the wholesale/warehouse level
• Provides product disposition of imported and domestic commercial product and clinical trial material
• Performs return product investigation and disposition
• Maintains a positive and productive liaison with internal and external contacts. This may include clients, regulatory agencies and related institutions
• Attends formal interactions (face-to-face meetings, teleconferences etc) with clients, and possibly, government agencies
• Performs Annual Product Quality Reviews (APQRs) and assists in Management Reviews
• Collects and reviews stability data for assigned projects/clients
• Collects product and client information for product/client files and the Master Product Binder
• Reviews and assesses for compliance against complex technical documents such as Quality Agreements, regulations and registration files
• Supports agency, client and/or self-inspections and aids in maintaining a state of audit-readiness
• Supports temperature studies and sensor qualification at applicable facilities
• Responsible for supporting project workflow, including prioritizing project objectives for smaller projects and portions of larger projects, and establishing timeframes for projects with guidance from senior team members
• Responsible for overseeing progress and completion of their own projects/assignments ensuring timeframes and deadlines are met
• Supports request of Certificate of Pharmaceutical Products (CPP)
• Supports DEL submissions and Vendor Qualification program
• Maintains current GMP knowledge
• Supports Business Operations by completing other appropriate duties as assigned by your People Leader

Qualifications:

• Minimum of a Bachelor's Degree, Life Sciences preferred
• Comprehensive experience in Quality including knowledge of current GMP in Canada, Good working knowledge of ICH 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.
• Ability to build positive, productive relationships with colleagues and clients.
• Advanced level in written English, intermediate level in oral English. Ability to speak and write French is an asset.

Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.