Director, Product Quality Assurance

BWXT Medical Ltd. is a trusted source for the development and manufacture of nuclear medicine for biotechnology, life sciences, pharmaceutical companies and academia partners.

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.

On-site in Kanata, Ontario

• Ensure the efficient and cost‑effective operation of the Quality Assurance to meet, and where possible exceed, all customer expectations with respect to product and service quality.
• Maintain the Quality System within the Medical Isotope business unit.
• Act as the Management Representative according to ISO
  13485:2016 requirements and the Quality Manual, QSF‑00.
• Administer the Internal Audit system to ensure company‑wide compliance with regulations, standards, QA manuals and related procedures.
• Create, implement and maintain all required QA systems for compliance.
• Coordinate Management Review team meetings, including preparation of Quality System Reports that summarize the status of the Company Quality System.
• Ensure appropriate registrations for new or changing products occur, including FDA, Health Canada, EMEA regulations and guidance, ISO 9001, ISO 13485.
• Direct the creation, monitoring and maintenance of cGMP systems for manufacture of parenteral drug, API and Medical Device products, and provide knowledgeable QA resources for product and process development initiatives.
• Manage QA education programs, including GMP and other specific training programs.
• Coordinate external regulatory audits, preparing, training and coaching staff from all relevant areas of the company; lead regulatory, registrar and notified body audits and manage all outcomes.
• Establish duties and responsibilities of direct reports and delegate authority as appropriate.
• Develop objectives and strategies to meet the overall objectives of the Business unit.
• Direct the department to ensure Medical Isotopes business objectives are achieved.

• University Honours Degree in Science (life sciences or chemistry) plus 10 to 12 years of experience in quality assurance or a similar external‑regulated environment.
• Sound understanding of quality assurance issues in the context of external regulation.
• Ability to manage a professional group and influence senior management and professionals within the organization.
• Analytical ability to judge the adequacy of quality assurance and participate in the resolution of problems.
• Ability to determine and defend product disposition when decisions are questioned internally or externally by customers or regulators.

Base salary range (Ontario, CA‑ON) at start of employment: $138,000 to $188,000 per year, subject to local market factors and candidate qualifications. Total compensation may also include an annual cash incentive and full medical, retirement, and other benefits.

• Comprehensive Health Benefits – health, dental, vision, and disability coverage.
• Defined Contribution Pension Plan and optional company‑matched retirement savings plans (RRSP/TFSA/EPSP).
• Work‑life balance – flexible hybrid schedules and compressed workweek options.
• Referral bonuses – earn generous referral bonuses ($1,500 and $3,000) through our two‑tiered employee referral program.
• Educational Refund Plan – up to $5,250 USD per year.
• Professional Development – training, certifications, and growth opportunities.
• Wellness – gym membership discounts and mental health support programs.
• Diverse, inclusive, supportive culture that celebrates self‑expression.
• Team‑building activities organized by the Social Committee.

BWXT Medical Ltd. embraces diversity of thought, values individuality, encourages new perspectives, and provides equal opportunity to all qualified employees and applicants without regard to race, national or ethnic origin, colour, religion, age, sex, sexual orientation, marital status, family status, disability, or any other category protected by federal law. BWXT Medical Ltd. is committed to fostering an accessible, fair, and inclusive environment where all employees can access goods and services while being respected and supported.

Accommodations during the application or interview process may be requested. If needed, please contact Human Resources for accessible information or assistance.