Manager, Global Quality Management System (QMS)

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� Description

• • Own the heartbeat of Orca Bio’s global Quality Management System (QMS) as the Manager, Global QMS. In this high-impact, fully remote role you will orchestrate the processes that keep our investigational cell therapies on track to transform the lives of more than one million blood-cancer patients. You will be the single point of accountability for critical quality pillars—Quality Management Review (QMR), internal audits, supplier qualification, and inspection readiness—ensuring every site, system, and partner operates to the same uncompromising standard.
• • Lead and continuously evolve the global Quality Management Review (QMR) process. You will design the data-collection architecture, set review cadences, and distill complex quality metrics into concise, decision-ready briefings for senior leadership. Your insights will directly influence resource allocation, risk tolerance, and strategic direction across a multi-site, pre-commercial organization.
• • Direct the global internal audit program end-to-end. From annual risk-based planning through on-the-ground execution, report generation, and CAPA tracking, you will ensure every audit strengthens our scientific and compliance posture. You will coach auditors, mentor site leads, and transform findings into systemic improvements that prevent recurrence.
• • Own the supplier qualification and management program. You will conduct risk assessments, schedule and lead GxP audits, negotiate quality agreements, and maintain a living supplier scorecard. By ensuring raw materials, critical reagents, and contract services meet or exceed regulatory expectations, you will de-risk the supply chain that feeds our manufacturing pipeline.
• • Drive global inspection readiness. You will create and rehearse mock-FDA, EMA, and PMDA inspections, maintain inspection war rooms, and ensure rapid-response dossiers are always current. When regulators arrive, you will serve as a primary interface, demonstrating Orca Bio’s culture of quality and scientific rigor.
• • Provide dotted-line leadership to site QMR administrators. Through regular forums, playbooks, and one-on-one coaching, you will harmonize interpretation of standards and ensure consistent implementation of global procedures across Menlo Park, remote manufacturing partners, and future international sites.
• • Establish and monitor global QMS KPIs. You will design dashboards that translate quality data into predictive insights, enabling proactive interventions before trends become crises. Your metrics will be the common language used by Quality, Operations, Clinical, and Executive teams to measure progress toward our mission.
• • Partner with IT and business process owners to enhance electronic QMS platforms (MasterControl, TrackWise, ERP modules). You will author user-requirement specifications, prioritize enhancements, oversee validation protocols, and ensure 21 CFR Part 11 compliance—turning technology into a competitive advantage.
• • Review and approve validation documentation for global enterprise systems and manufacturing equipment. Whether it is a new bioreactor skid, a LIMS upgrade, or a cold-chain logistics sensor network, you will ensure qualification packages meet FDA, EMA, and internal standards before go-live.
• • Champion continuous improvement. Using lean-six-sigma tools, you will facilitate kaizen events, sponsor root-cause investigations, and embed a culture where every employee sees quality as their job. Your initiatives will shorten batch release times, reduce deviations, and accelerate patient access to life-saving therapies.
• • Represent Quality in external forums. From industry consortiums to regulatory workshops, you will share Orca Bio’s story, benchmark best practices, and bring external insights home to keep our QMS future-proof.
• • Thrive in a fast-moving, pre-IPO environment where science, urgency, and compassion intersect. You will balance rigorous compliance with entrepreneurial agility, proving that quality is not a constraint but an enabler of innovation.