Position Summary We are seeking an experienced Senior Project Manager (Remediation Subject Matter Expert) to lead and coordinate complex remediation programs within regulated environments. The ideal candidate will possess strong expertise in quality systems, compliance remediation, CAPA management, regulatory inspections, and cross-functional project leadership. This individual will drive remediation initiatives from assessment through implementation, ensuring compliance with applicable regulations and industry standards.

Key Responsibilities Lead large-scale remediation programs resulting from regulatory inspections, audits, quality system assessments, and compliance gaps. Develop and maintain remediation project plans, timelines, risk registers, and status reports. Coordinate cross-functional teams, including Quality, Regulatory Affairs, Manufacturing, Engineering, Validation, Supply Chain, and Operations. Conduct gap assessments and root cause analyses to identify compliance deficiencies and remediation requirements. Drive CAPA development, execution, effectiveness verification, and closure activities. Monitor project milestones, deliverables, budgets, and resource allocation. Facilitate governance meetings, executive reviews, and stakeholder communications. Ensure remediation activities align with FDA, Health Canada, EU MDR, GMP, GCP, GLP, ISO 13485, and other applicable regulatory requirements. Support inspection readiness activities and responses to regulatory observations (FDA 483s, Warning Letters, consent decrees, audit findings, etc.). Track remediation metrics and provide leadership with progress updates and risk mitigation strategies. Collaborate with external consultants, regulatory agencies, and business partners as required.

Required Qualifications Bachelor's degree in Life Sciences, Engineering, Pharmacy, Chemistry, or related field. 10+ years of experience in Pharmaceutical, Biotechnology, Medical Device, or Healthcare regulated industries. 5+ years of project management experience leading compliance or remediation programs. Strong knowledge of GMP, Quality Systems, CAPA, Change Control, Risk Management, and Regulatory Compliance. Experience managing remediation efforts associated with FDA inspections, Health Canada audits, ISO audits, or consent decree activities. Demonstrated ability to lead cross-functional teams and influence senior stakeholders. Excellent communication, presentation, and organizational skills. Proficiency with project management tools such as MS Project, Smartsheet, Jira, or similar.

Preferred Qualifications PMP Certification preferred. ASQ certifications (CQE, CQA, CMQ/OE) preferred. Experience with Quality Management Systems (TrackWise, MasterControl, Veeva, ETQ, etc.). Prior consulting experience supporting remediation initiatives.