Role overview

Leads the inspection readiness program for a solid-dose manufacturing site and a packaging site under an active quality remediation project. Owns the near-term Health Canada readiness plan and the longer-term readiness framework, preparing the sites, documents and SMEs for Health Canada and FDA inspections.

Key responsibilities
Set up readiness governance and the annual readiness plan; run a risk-based readiness assessment of both sites
Build the near-term Health Canada readiness plan (first 8 weeks), separate from the full remediation plan
Prepare site profiles, inspection logistics, tour plans and the front/back-room and document-room set-up
Develop storyboards for high-risk topics and maintain the document index and readiness gap tracker
Select, train and coach SMEs and backup SMEs; run mock interviews
Plan and lead multi-day mock inspections and issue reports with gap trackers




Track health-authority commitments and support response drafting (no direct authority communication)
Report readiness status to the PMO and QIP Steering Committee

Mandatory requirements
10+ years of GMP quality experience in the pharmaceutical industry
Has personally led Health Canada and/or FDA inspection preparation (front room / back room / SME coaching)
Experience running mock inspections and building storyboards
Experience in remediation contexts (post-483, Warning Letter, Health Canada observations or similar)

Plus the common requirements listed on page 1.

Preferred qualifications
Experience with solid oral dosage manufacturing and packaging sites
Direct experience hosting or supporting Health Canada inspections
Former regulator, auditor or site Head of Quality / Compliance
Experience working in a multi-workstream PMO-governed program

📌 Inspection Readiness Lead Toronto (Canada)
🏢 United Pharma
📍 Canada