Site Quality Head

Role overview

Responsibilities

• Oversee quality assurance activities and maintain regulatory compliance.
• Ensure products manufactured, tested, and released from the site meet global requirements and company quality standards.
• Build and implement quality systems and a culture of excellence.
• Lead quality initiatives and collaborate to improve business outcomes.
• Lead and develop large quality teams and collaborate across organizational levels.
• Work with external regulatory authorities and manage inspections.

Requirements

• Bachelor’s or advanced degree in life sciences, engineering, pharmaceutical sciences, or a related field.
• 12 to 15 years of pharmaceutical manufacturing experience, including significant quality leadership.
• Strong knowledge of oral solid dose manufacturing, cGMP requirements, and regulatory expectations.
• At least 5 years of experience as a site quality lead.
• Expertise in FDA CFR 820, ISO 13485/9001, MDR, and ISO 14971 risk management.
• Experience managing CAPA systems and quality improvement initiatives; proficiency in FMEA, SPC, and risk management methods.
• Experience with PPI, 8D, DMAIC, and PPS problem-solving methods.
• Experience leading and developing large teams, including 8–10 direct and 100+ indirect reports.
• Experience with regulatory authorities and inspections; ability to build cross-functional partnerships.
• Strategic planning and execution experience, including transitioning from quality control to quality assurance.
• Strong communication, presentation, change management, and organizational development capabilities.
• Ability to travel 25–30% of the time.

Preferred qualifications

• ASQ Quality Manager Certification and ASQ Lead Auditor Certification are preferred.
• Experience with Lean or Six Sigma improvement systems is preferred.
• Electromechanical manufacturing experience is preferred.

Compensation

• Estimated annualized pay range in Ontario is $160,000.00–$200,350.00.

Schedule

• Standard Monday-to-Friday work schedule.

Workplace

• Environmental conditions are described as office.