Publié il y a 13 jours
Inspection Readiness Lead
@ United Pharma
Toronto, Ontario
En bref
United Pharma is hiring a contract Inspection Readiness Lead for a solid-dose manufacturing site and a packaging site under an active quality remediation project. The role owns the near-term Health Canada readiness plan and the longer-term readiness framework, preparing sites, documents and SMEs for Health Canada and FDA inspections. The posting requires 10+ years of pharmaceutical GMP quality experience and prior inspection preparation and remediation work.
Responsabilités :
- Lead inspection readiness program for two sites
- Build Health Canada 8-week readiness plan
- Develop storyboards and prepare SMEs
- Plan and lead multi-day mock inspections
- Track health-authority commitments and report to PMO
Résumé des exigences :
- 10+ years GMP quality experience in pharmaceuticals
- Personally led Health Canada or FDA inspection preparation
- Experience running mock inspections and storyboards
- Remediation experience (483, Warning Letter, Health Canada observations)
Source et dates
Type de source non vérifié · apify-linkedin
- Date publiée par l’employeur
- 2026-10-28
- Première détection par notre source
- 2026-11-11
- Mise à jour du dossier source
- 2026-11-11
Ces dates décrivent le dossier source, pas une vérification en direct du recrutement. Consultez l’offre originale.
Détails du poste
| Niveau | Chef d’équipe |
| Domaine | Assurance qualité |
| Expérience | 10 an(s) et plus |
| Milieu de travail | Bureau, Usine |
| Position | Surtout assis |
| Exigences physiques | physique faible · ordinateur élevé |
| Langues | English |
Résumé et détails rédigés par l’IA à partir de l’offre; l’offre de l’employeur fait foi.
United Pharma
| Champ | Valeur |
|---|---|
| Offres sur Jobsy | 5 |
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
Journal
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