Project Manager – Global QMS Transformation (Bio Pharma)

• *Project Manager – Global QMS Transformation** • *(Lifecycle, Maintenance, Calibration) – 100% Remote** • *This is a 9–12-month engagement with the potential for extension based on program needs and performance.** • ***** • *Project Manager – Global QMS Transformation (Bio/Pharma)** • ***** • *About PharmAllies** PharmAllies partners with life sciences organizations to deliver critical initiatives across project management, operational excellence, quality systems, CQV, and digital transformation. Our approach is grounded in experience. We bring professionals who understand how work actually gets executed across sites, functions, and global teams. We focus on building alignment, driving accountability, and delivering outcomes that are sustainable beyond project completion. We are currently supporting a global biopharmaceutical client in the execution of a large-scale Quality Management System transformation program. • *Position Overview** This role supports a global program focused on standardizing and modernizing quality processes across 36 sites. The effort is part of a broader initiative to align Lifecycle Management, Maintenance, and Calibration under a consistent global framework. Global SOPs and Work Instructions are being developed. The priority now is ensuring that these standards are effectively implemented, adopted, and sustained across the network. You will support the Global Engineering workstreams by bringing structure to execution, maintaining alignment across stakeholders, and ensuring that site-level adoption stays on track. • *Work Location** This role is fully remote. The position supports a global program, so flexibility to accommodate multiple time zones is expected. • *Engagement Duration** This is a 9–12-month engagement with the potential for extension based on program needs and performance. • *Key Responsibilities** : Develop and maintain the global rollout plan covering Lifecycle Management, Maintenance, and Calibration deliverables, including SOPs and Work Instructions. Coordinate execution activities across Global Process Owners, Local Process Owners, and site leads. Maintain a single, integrated tracker across all workstreams. Track milestones, ownership, dependencies, and execution status across approximately 36 sites. Identify risks, assess impacts, and support escalation when required. Track site readiness, including training completion, impact alignment, and transition planning. Coordinate with stakeholders to ensure readiness activities are progressing toward closure. : Coordinate site gap assessments against approved Global SOPs and Work Instructions. Track remediation actions and monitor progress toward closure to support implementation timelines. Support the program operating rhythm, including meeting coordination, action tracking, and follow-up. Develop KPI-based reporting to provide visibility into program status, including: • Document approval and release status • Gap assessment completion and remediation progress • Training completion • Implementation readiness and site adoption Provide clear, concise reporting to support Global Process Owner review and decision-making. • *Required** • 5+ years of experience in project management, PMO, or program coordination • Experience supporting complex, multi-deliverable initiatives • Strong organizational and stakeholder management skills • Proficiency with Excel-based trackers and collaboration tools such as Teams and SharePoint • *Preferred** • Experience in life sciences, manufacturing, engineering, or quality environments • Exposure to global or multi-site program execution • Familiarity with structured governance and program cadence • *Working Style** You are organized, consistent, and reliable in execution. You are comfortable working across global teams and managing multiple priorities without losing clarity. You bring structure to complex environments and maintain focus on follow-through. • *Why This Role Matters** This role sits at the center of execution. The success of the program depends on how effectively global standards are translated into consistent site-level implementation. You will help ensure that the program moves beyond documentation and delivers real operational alignment across the network. • *How to Apply** Please submit your resume in Word format to [email protected] P26-00001 Application Question(s) • Do you have experience coordinating gap assessments and tracking the implementation of Global SOPs and Work Instructions within a regulated environment (e.g., Life Sciences, Manufacturing, or Engineering)? • This position requires maintaining a single, integ