At ICON, it\xe2\x80\x99s 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\xe2\x80\x99 lives.

Our \xe2\x80\x98Own It\xe2\x80\x99 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\xe2\x80\x99s our vision. We\xe2\x80\x99re driven by it. And we need talented people who share it.
If you\xe2\x80\x99re as driven as we are, join us. You\xe2\x80\x99ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you\xe2\x80\x99ll be helping shape an industry.
We are looking for passionate, resilient, and inspiring individuals to join our team. As the Manager, Regulatory Quality Services, you are responsible for all Quality duties to support clients, agency and client inspections, SOPs, quality agreements, product disposition pre and post market. The role also ensures adherence to current GMP\xe2\x80\x99s and can be called on for Pharmaceutical Drugs. The role

• Manages client projects, including managing client relationships and project budgets
• Communicates with appropriate health agencies to maintain internal Establishment License, as well as client specific Establishment Licenses, foreign sites and table A (specific to Health Canada) to ensure compliance
• Prepares, assists and leads agency and client audits
• Acts as client Quality unit; works with clients on deviations, change controls, customer complaints, recalls, and other key quality systems
• Assists with investigations and disposition of product
• Reviews key documentation such as Master Production Documents, SOPs, stability, validation, vendor management, QA Agreements, and APQRs
• 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 possible, government agencies
• Prioritizes and completes multiple concurrent projects within established time frames
• Maintains product and client files/records
• Supports requests for Certificate of Pharmaceutical Products (CPP)
• Maintains current GMP knowledge
• Supports business operations by completing other appropriate duties as assigned by your people leader

What you need

• A minimum of a Bachelor\xe2\x80\x99s degree or local equivalent
• 5-8 years related experience, strong knowledge of Health Canada Drug Establishment Licences (DEL)
• Prior experience working in a GMP environment/knowledge of GMP standards
• Subject Matter Expert on Health Canada Guide-0001, 0002, 0080, & 0127
• Proven leadership, ability to consult and represent clients

Why join us?

• 
  You will be working to accelerate the delivery of new therapies to patients
• Ongoing development and the opportunity to progress your career, with the potential to move into other related areas to improve your skill set
• You will have creative resources to be successful in delivering results, inspiring others and becoming a trusted partner

Benefits of Working in ICON:
Our success depends on the quality of our people. That\xe2\x80\x99s why we\xe2\x80\x99ve 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 \xe2\x80\x93 both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans \xe2\x80\x93 and related benefits such as life assurance \xe2\x80\x93 so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you\xe2\x80\x99ll 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.