Job SummaryWe are seeking an experienced Project Manager to lead and oversee a Standard Operating Procedure (SOP) Review and Modernization Program within a highly regulated industry environment. The Project Manager will be responsible for end-to-end project planning, execution, governance, stakeholder engagement, and performance monitoring to ensure the successful review, remediation, modernization, approval, training, and implementation of SOPs. This role requires strong project management expertise, experience working in biotechnology environments, and the ability to coordinate cross-functional teams while driving schedule adherence, quality outcomes, and continuous improvement initiatives. The Project Manager will also play a key role in collecting and analyzing pilot-phase performance data to support future program planning and scalability.
Employment type: Full time and onsite roleKey Responsibilities & Project ScopeProject Leadership and Execution- Lead project planning, execution, monitoring, and closeout activities for the SOP Review and Modernization Program. Develop and maintain detailed project plans, schedules, milestones, and deliverables. Coordinate resources and manage workloads across multiple workstreams and stakeholder groups. Monitor project progress and ensure timely achievement of key milestones and objectives. Identify project risks, develop mitigation strategies, and manage escalation processes as needed.
Governance and Stakeholder Management- Serve as the primary liaison between the Project Sponsor and project stakeholders. Coordinate and facilitate project governance activities, including steering committee meetings, status reviews, and decision-making forums. Provide regular project status updates, executive summaries, and performance reports. Ensure alignment among business, quality, regulatory, and operational stakeholders throughout project execution.
SOP Modernization Oversight- Oversee SOP review, remediation, approval, training, and implementation activities. Ensure compliance with applicable regulatory requirements, quality standards, and internal governance processes. Coordinate subject matter expert (SME) participation and support efficient review and approval cycles. Monitor comment resolution activities and drive timely closure of review feedback.
Performance Measurement and Reporting- Develop, implement, and monitor key performance indicators (KPIs) to measure project success. Collect, analyze, and report project performance data throughout the pilot phase. Produce data-driven insights and recommendations to support future program planning and execution.
Required Qualifications- Bachelor's degree in business, Life Sciences, Engineering, Quality Management, or a related field.
- 5+ years of project management experience, preferably within pharmaceutical, biotechnology, medical device, healthcare, or other regulated industries.
- Demonstrated experience managing document remediation, SOP lifecycle management, quality systems, or process improvement initiatives.
- Strong understanding of project management methodologies and governance frameworks.
- Experience developing KPIs, dashboards, and performance reporting.
- Excellent stakeholder management, communication, and facilitation skills.
- Proficiency with project management tools and reporting platforms.
Preferred Qualifications- PMP, PRINCE2, or equivalent project management certification.
- Experience supporting GxP, Quality Management Systems (QMS), or regulatory compliance initiatives.
- Knowledge of change management and organizational readiness practices.
- Experience with SOP modernization, document management systems, or quality process transformation programs.
