Director, Regulatory Quality Services

Director, Regulatory Quality Services

At ICON, it's our people that 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 and dossier management servicesAs 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 roleManage and oversee the SRS Quality teamAct as Head of Quality for Clients and for ICONs GMP certified entity C.R.I. , located in Toronto Canada, to ensure that satisfactory GMP/GCP controls are in place and SOPs are followedServe as a resource for SRS team members and colleagues, providing advice on project and regulatory strategiesPrioritize and manage client projects, including managing client relationships and budgetsPrepare, assist and lead agency and client audits, all the while maintaining a positive working relationshipIdentify client issues and develop effective strategiesMaintain current GMP knowledge, as well as global awareness of Quality issues and other Regulatory agency approachesProvide strategic Quality advice across DepartmentsIdentify business development opportunities, participate in or conduct potential client consultation and proposal preparation to bring in new clientsProvide thought leadership, Speak at conferences and webinars, as appropriate

What you needMinimum of 12-15 years related experiencePrior experience in a Pharma or CRO manufacturing environmentMinimum of a Bachelor's degree or local equivalentPrior experience in drug importHave recent, ongoing experience in a GMP regulated environmentIdeally be located in Toronto 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.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin