Manager, Manager, Quality Validation &Engineering
On-site · Richmond Hill, Ontario, Canada
Job Summary
Quality Validation & Engineering Manager at Apotex Richmond Hill site responsible for validating GMP facilities, utility systems, equipment, and processes for sterile and non-sterile manufacturing. Provides QA direction and approval for validation activities (aseptic process simulations/media fills; aseptic operator qualification; thermal and gaseous validation; irradiation of packaging components; container closure integrity; sterilizing filter validation) and for maintenance/validation of facilities, utilities, equipment, manufacturing processes, calibration and change control. Acts as QA SME in investigations related to validation, calibration, and maintenance; supports regulatory submissions and audits; ensures compliance with Canadian and international GMP requirements; leads cross-functional projects; provides performance coaching and fosters a culture of trust and development; involved in talent attraction and onboarding; salary range CAD 109,933.56 - 153,906.98 CAD with total rewards and accommodation options. Educational requirement includes Bachelor of Science (preferably MSc) with 7-10 years GMP experience and 5 years of management experience. Location: Richmond Hill, Ontario, Canada.
Required Qualifications
- Bachelor of Science Degree in Applied Sciences and/or Pharmaceutical Engineering
- Minimum 7-10 years of experience in a GMP-regulated industry
- 5 years of management experience in pharmaceutical or equivalent industry
- Experience in validation roles including process validation, equipment validation, and change control
- Proven ability to interact with regulatory agencies in audits
- Strong knowledge of GMP and regulatory requirements
- Excellent problem-solving, organizational, and communication skills
- Experience with statistical process control and risk management tools (e.g. FMEA)
- Proficiency with Microsoft Office tools
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.