Project Manager

Remote

Seeking an experienced Senior Project Manager to support global Quality Control technology implementation initiatives in a regulated biotech/pharma environment. This role will manage high-level, complex, cross-functional projects within defined scope, quality, timeline, and cost expectations to deliver agreed business and operational requirements. The Project Manager will coordinate global and site-level workstreams, maintain integrated project plans, manage risks, issues, dependencies, decisions, and action items, and ensure project objectives and requirements are clearly documented.

Responsibilities include coordinating project team activities, supporting resource planning, facilitating governance forums, preparing executive-level status updates, and driving alignment across QC, Quality, IT, Validation, Regulatory, and site stakeholders. The role may support multiple phases of the implementation lifecycle, including requirements gathering, business process analysis, design, testing, implementation planning, change management, training readiness, procedural updates, qualification/validation readiness, regulatory readiness, and operational handoff.

The ideal candidate has demonstrated experience running medium to large-scale projects, strong knowledge of project management processes and best practices, excellent analytical and communication skills, and the ability to work effectively across cross-functional teams and management levels. Experience with business process development, change management, collaboration tools, and project documentation tools such as MS Project, Excel, PowerPoint, Word, Smartsheet, or equivalent is strongly preferred. Familiarity with GMP Quality Control operations, laboratory systems, data integrity, SOPs, change controls, and qualification/validation activities is highly desirable.