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
