Senior Regulatory -Subject Matter Expert (Laboratory Operations) (Ottawa)

Position Summary

We are seeking an experienced Senior Regulatory / GMP Subject Matter Expert (SME) to support laboratory quality and compliance initiatives within a regulated pharmaceutical, biotechnology, or life sciences environment. The ideal candidate will possess extensive knowledge of GMP regulations, laboratory quality systems, regulatory expectations, and remediation programs. This role will be responsible for assessing current laboratory practices, identifying compliance gaps, developing corrective action strategies, and overseeing implementation activities to ensure regulatory readiness and operational excellence. Key Responsibilities

Establish and maintain a documented surveillance process to monitor laboratory compliance with GMP regulations, internal procedures, and industry best practices. Conduct comprehensive gap assessments of existing Quality Control (QC) laboratory methods, processes, procedures, systems, and documentation against applicable regulatory standards and guidance. Evaluate laboratory operations for compliance with FDA, EMA, ICH, WHO, and other relevant regulatory requirements. Identify deficiencies, compliance risks, and process improvement opportunities within QC laboratory functions. Develop detailed reports summarizing assessment findings, observations, risk evaluations, and recommended remediation actions. Create a phased corrective action and remediation plan with defined priorities, timelines, resource requirements, and deliverables. Collaborate with Quality Assurance, Quality Control, Validation, Manufacturing, and Regulatory Affairs teams to align remediation activities with business objectives. Lead and support the implementation of corrective and preventive actions (CAPA) to address identified compliance gaps. Provide GMP and regulatory guidance to laboratory personnel during process improvements and compliance initiatives. Review and update laboratory procedures, work instructions, and quality system documentation as needed. Support regulatory inspections, internal audits, and mock audits by ensuring laboratory readiness and compliance. Monitor the effectiveness of implemented corrective actions and recommend additional improvements where necessary. Drive continuous improvement initiatives to strengthen laboratory quality systems and regulatory compliance. Required Qualifications

Bachelor's or Master's degree in Life Sciences, Chemistry, Microbiology, Pharmaceutical Sciences, Engineering, or a related discipline. 10+ years of experience in GMP-regulated pharmaceutical, biotechnology, or medical device environments. Extensive knowledge of QC laboratory operations, GMP regulations, CAPA systems, and quality management systems. Proven experience conducting regulatory compliance assessments and remediation projects. Robust understanding of FDA 21 CFR Parts 210, 211, 11, ICH guidelines, and global GMP requirements. Experience supporting regulatory inspections and audit readiness activities. Excellent analytical, problem-solving, communication, and stakeholder management skills. Preferred Qualifications

Previous experience serving as a GMP Compliance Consultant or Regulatory SME. Experience leading large-scale laboratory remediation and quality transformation projects. Certification in Quality, Regulatory Affairs, or GMP-related disciplines is a plus. Deliverables

Documented Surveillance Process Comprehensive QC Laboratory Gap Assessment Report Phased Corrective Action and Remediation Plan Successful Implementation of Corrective Actions Enhanced GMP Compliance and Inspection Readiness

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