Senior Regulatory / GMP SME (QC Laboratory) at Intellectt INC — NeverHard

Hello, I hope you're doing well. My name is Jayadev, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Senior Regulatory / GMP SME (QC Laboratory) based in Ottawa, Ontario, Canada with one of our prestigious clients. I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at jayadev.g@intellectt.com Job Title : Senior Regulatory / GMP SME (QC Laboratory) Location : Ottawa, Ontario, Canada Job Summary: Seeking a Senior Regulatory & GMP Subject Matter Expert with strong QC Laboratory experience to assess GMP compliance, perform gap assessments, support remediation activities, and ensure regulatory readiness within pharmaceutical/biotech environments. Key Skills: GMP Compliance QC Laboratory Operations Data Integrity GMP Gap Assessments Regulatory Inspections (FDA, Health Canada, Global Agencies) CAPA Management Deviations, OOS & OOT Investigations SOP Review & Compliance Quality Systems Laboratory Controls Audit & Inspection Readiness Remediation Planning Risk Assessment Corrective Action Implementation Requirements: 10+ years of GMP Quality / QC Laboratory experience Expertise in GMP regulations and regulatory expectations Hands-on experience with compliance assessments and remediation programs Experience supporting FDA, Health Canada, and international regulatory inspections Strong understanding of Quality Systems and Data Integrity principles Preferred Industry: Pharmaceuticals | Biotechnology | Life Sciences | Medical Devices | CRO/CDMO Thanks Regards, JAYADEV Sourcing Specialist Phone (732)-997-6982 Ext: 308 Email jayadev.g@intellectt.com