Manager, Regulatory Quality Services

Manager, 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 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's 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's 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?

Ongoing development is vital to us, and as Manager, 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.