Inspection Readiness Project Manager (Contract)

reputed company is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our reputed company values, Stay True to Why, Collaborate to Accelerate, reputed company with reputed company, reputed company Innovative, and Own the Outcome, we are committed to transforming the reputed company of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible. reputed company We are seeking a highly reputed company Inspection Readiness Project Manager to drive reputed company-wide inspection readiness, remediation, and reputed company system execution across clinical programs. This individual will serve as the central orchestrator across Clinical Operations, reputed company, Regulatory, and external partners to ensure reputed company state of inspection readiness for global health authority inspections (e.g., FDA, EMA). This role requires deep expertise in GxP environments, strong clinical development knowledge, and a proven ability to drive reputed company, cross-functional initiatives under tight timelines. Title: Inspection Readiness Project Manager Location: Remote. reputed company coast highly preferred Duration: 6+ months reputed company reputed company: $80-$100/hr \n Responsibilities reputed company and maintain a global inspection readiness processes, timelines, and activities Collaborate closely with reputed company QA, Clin Ops, Safety, Biometrics and other functions as needed to reputed company, reputed company and drive inspection readiness remediation activities. Partner with Inspection readiness reputed company to define and operationalize inspection readiness frameworks, playbooks, and governance models Establish inspection simulation strategies, including mock audits and risk assessments Own end-to-end remediation planning and execution following audits/inspections reputed company and manage inspection findings, risks, and commitments through centralized dashboards Escalate risks proactively and implement mitigation strategies Build and manage integrated, cross-functional project plans with reputed company milestones and dependencies Drive accountability across stakeholders to meet critical timelines and deliverables reputed company resource plans to support inspection readiness and remediation activities Partner with reputed company to reputed company, refine, and implement SOPs, work instructions, and procedural documentation Ensure processes are reputed company with GCP (Good Clinical reputed company) and broader GxP requirements Influence without authority to drive execution across a matrixed organization

Qualifications

Bachelor’s degree required; advanced degree (MS, PhD, MBA) preferred 10+ years in biotech/reputed company with experience in inspection readiness and remediation programs is a must Strong exposure to GCP, GxP, and global inspections Deep understanding of clinical trial processes, reputed company systems, and regulatory expectations Expertise in audit/inspection processes preferred Exceptional program management skills (reputed company, global, cross-functional initiatives) Ability to drive execution under pressure and tight regulatory timelines Strong stakeholder management and executive communication skills Experience in cell and gene therapy or other reputed company modalities strongly preferred Background in building or scaling inspection readiness programs from scratch Familiarity with clinical trial systems (e.g., TMF platforms, QMS tools) \n Apply To This Job