Position Overview:

The Director, Product Quality Assurance is a senior leadership role responsible for defining, implementing, and overseeing the quality assurance strategy for all products across the drug product lifecycle. This role ensures that products meet the highest standards of safety, reliability, regulatory compliance, and customer satisfaction

Location:

On-site in Kanata, Ontario

Your Day to Day as a Director, Product Quality Assurance:

Within the general framework of the quality objectives, legal requirements for product approval and licensing, and the strategic plans of the Company, is responsible for and has the authority to accomplish the following duties in the Medical Isotope business unit, through direct involvement or the leadership of team members.

• Ensure the efficient and cost effective operation of the Quality Assurance in order to meet, and exceed where possible, all customer expectations with respect to quality of products and services.
• Maintain the Quality System within the Medical Isotope business unit.
• Functions as the Management Representative, according to the requirements of ISO13485:2016 and as defined in the Quality Manual, QSF-00.
• Administer The Internal Audit system to ensure company-wide compliance with the Regulations, standards, QA Manual and related procedures.
• Create, implement and maintain all required QA systems to ensure compliance
• Coordinate the Management review team meetings, including preparation of Quality System Reports that summarize the status of Company Quality System.
• Ensure the appropriate registrations for new or changing products occur. This includes, but is not limited to, FDA, Health Canada, EMEA regulations and guidance, ISO 9001, ISO 13485.
• Direct the creation, monitoring and maintenance of cGMP systems as required for manufacture of parenteral drug, API and Medical Device products. Provide sufficient knowledgeable QA resources for product and process development initiatives allowing for successful product registrations.
• Manage QA education programs including, but not limited to, GMP and specific education programs as needed for training.
• Co-ordinate external regulatory audits through organization, preparation, training and coaching of staff from all areas of the company that are involved. Lead regulatory, registrar and notified body audits. Manage all outcomes of regulatory audits.
• Establishes the duties and responsibilities of direct reports and delegates authority and responsibility as deemed appropriate.
• Develop objectives and strategies to meet the overall objectives of the Business unit.
• Directs the department to ensure Medical Isotopes business objectives are achieved.

Required Qualifications:

Normally University Honours Degree in Science (life sciences or chemistry) plus 10 to 12 years' experience working in quality assurance or other relevant environment, which is subject to external regulation.

• The work requires a sound understanding of quality assurance issues in the context of external regulation.
• Must possess ability to manage a professional group, and influence senior management and professionals within the organization.
• The incumbent must have the analytical ability to judge the adequacy of quality assurance and to participate in the resolution of problems.
• The incumbent must have the ability to determine and defend product disposition when the disposition decision is questioned internally or externally by the customer or regulator.

WHAT WE CAN OFFER YOU: Ensuring the well-being of our employees is our priority and we offer comprehensive and competitive benefits for our employees and their families.

• Comprehensive Health Benefits - Including health, dental, vision, and disability coverage to keep you feeling your best.
• Secure Your Future - Defined Contribution Pension Plan and an optional Company-matched retirement savings plans (RRSP/TFSA/EPSP)
• Work-Life Balance - Flexible hybrid schedules and compressed workweek option available
• Help Grow Our Team - Earn generous referral bonuses with our two-tiered
• Employee Referral Program ($1,500 and $3,000!).
• Invest in Your Education - Up to $5,250 USD per year through our Educational Refund Plan.
• Professional Development - Gain access to training, certifications, and growth opportunities to advance your career.
• Your Wellness Matters - Enjoy gym membership discounts and access to mental health support programs.
• A Welcoming Workplace - Join a diverse, inclusive, and supportive culture that celebrates you.
• Fun & Connection - Engage in team-building activities organized by our Social Committee.Ready to grow with us?

Apply now and let's build something amazing together!

The base salary range for this position in Ontario (CA-ON) at the start of employment is expected to be between $138,000 and $188,000 per year. However, the base salary offered is based on local job market factors and may vary further depending on factors specific to the selected job candidate, such as job-related knowledge, skills, experience, and other objective business considerations. Subject to these considerations, the total compensation package for this position may also include other elements, such as an annual cash incentive in addition to a full range of medical, retirement, and/or other benefits. Details of participation in these benefit plans will be provided at such time the selected job candidate receives an offer of employment.