Director, Regulatory Quality Services

Director, Regulatory Quality Services

At ICON, our people set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

We are looking for passionate, resilient, and inspiring individuals to join our Strategic Regulatory Affairs (SRS) team. SRS are a global team of regulatory strategists from pharma, CRO and agency backgrounds, with expertise in drug development, regulatory strategy and operational implementation, CMC and quality assurance. We deliver global strategic regulatory consulting, dossier management services and GMP Quality services. As the Director, Regulatory Quality Services you will be responsible for the oversight of the Strategic Regulatory Services (SRS) Quality team who focus on conduct of Quality activities for clients ensuring adherence to GMPs and for growth and development of the team through business development activities.

The role

• Manage and oversee the SRS Quality team
• Act as Head of Quality for clients and for ICONs Canadian Drug Establishment Licenced entity, C.R.I., as the head of the qualified unit for clinical and commercial drug releases and to ensure maintenance of all aspects of GMP Quality Systems
• Serve as a resource for SRS team members and colleagues, providing advice on project and quality assurance strategies
• Prioritize and manage client projects, including managing client relationships and budgets
• Prepare, assist and lead agency and client audits, all the while maintaining a positive working relationship
• Identify client quality assurance and compliance issues and develop effective strategies
• Maintain current GMP knowledge for self and team, as well as global awareness of Quality issues and other Regulatory agency approaches
• Provide strategic GMP quality advice to clients and within the ICON organization
• Identify business development opportunities, participate in or conduct potential client consultations and proposal preparation to bring in new clients
• Provide thought leadership, speak at conferences and webinars, as appropriate

What you need

• Minimum of 12-15 years related experience in a Quality Assurance/Quality Systems setting, with emphasis on Canadian and US GMP
• Minimum of a Bachelor's degree or local equivalent
• Have recent, ongoing experience in a pharmaceutical GMP regulated environment
• Ideally be located in the Greater Toronto Area, Canada

Why join us?

Ongoing development is vital to us, and as a Director, Regulatory Quality Services you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.