Key Responsibilities Own and drive project management for QC's early-stage planning activities, including timelines, deliverables, and interdependencies with the broader site build Build and maintain relationships across construction, engineering, automation, EHS, quality, and operations teams to understand how workstreams connect and where QC has dependencies Track progress against milestones and proactively identify, escalate, and help resolve risks b Support planning for QC lab and equipment readiness, including coordination with analytical instrumentation and equipment vendors Help map and manage the relationships between validation activities (equipment, method, facility) and the broader project timeline during early-stage construction and startup Bring organization and rigor to a function that is still being defined.
Establish tracking tools, meeting cadences, and documentation as needed. Act as a connector across the site, networking effectively to identify the right stakeholders and keep information flowing between teams Qualifications Prior experience supporting GMP facility startups/new builds and understands the phases, pressure points, and typical team structures involved Familiarity with the range of teams and functions involved in a pharma/biotech site build (construction, engineering, automation, quality, EHS, operations, supply chain, etc.) Strong natural networker that builds relationships quickly and knows how to find the right person to unblock an issue Highly organized and ops-savvy; comfortable creating structure where little exists Not afraid to escalate risk early and directly and comfortable delivering difficult updates to leadership Exposure to analytical instruments/lab equipment procurement, installation, or qualification is a plus Working knowledge of validation relationships (IQ/OQ/PQ, commissioning and qualification) in the context of early-stage builds