Senior Specialist Global QMS

ABOUT THE ROLE Orca Bio is redefining the future of blood cancer treatment through next‑generation cell therapies that promise higher survival rates and lower risks than traditional allogeneic stem cell transplants. As a Senior Specialist, Global QMS, you will be a key driver in scaling our quality infrastructure to support commercial manufacturing and ongoing clinical programs. Your expertise will ensure that every site, supplier, and system meets the highest regulatory standards, enabling Orca Bio to deliver life‑changing therapies safely and efficiently. WHAT YOU'LL DO You will plan, schedule, and execute internal audits across all global sites, developing audit agendas, conducting interviews, and producing comprehensive reports that inform senior leadership. You will lead the global Quality Management Review process, collecting and analyzing data to provide actionable insights and KPI trends that drive continuous improvement. You will manage supplier qualification and ongoing monitoring, performing risk assessments and supplier audits to guarantee GxP compliance. You will coordinate inspection readiness activities for FDA, EMA, and other authorities, ensuring cross‑functional alignment and site preparedness. You will partner with IT and business process owners to identify, prioritize, and validate QMS system enhancements, including MasterControl, ERP, and Trackwise. Finally, you will provide oversight to site QMR administrators, ensuring consistent implementation of quality systems across the organization. WHAT YOU'LL NEED A bachelor’s degree in a scientific or engineering discipline, with an advanced degree preferred, and at least five years of quality assurance experience in a GxP‑regulated environment, including two to three years in a leadership role. You must possess deep knowledge of FDA, EMA, ICH, ISO 9001, 21 CFR Parts 210/211/820, and EU GMP regulations. Proven success in leading internal audit programs, supplier management, and validation oversight is essential. You should be adept at establishing and trending quality performance metrics and KPIs, and experienced with electronic QMS systems and IT collaboration. Strong organizational, analytical, and communication skills are required, with a demonstrated ability to influence and collaborate across functional and site boundaries. Experience in a multi‑site or global quality organization is strongly preferred. WHY REMOTE Orca Bio embraces a distributed, asynchronous culture that empowers employees to work from any location while staying connected through collaborative tools and regular virtual touchpoints. The remote model offers flexibility to balance professional responsibilities with personal life, fostering creativity and productivity. Our teams operate on a results‑oriented cadence, allowing you to structure your day around key deliverables and maintain high performance without the constraints of a traditional office environment. BENEFITS Competitive salary range of $90,000 to $120,000 plus pre‑IPO equity and annual bonus; comprehensive medical, dental, and vision coverage; paid time off, 401(k) with company match, life and accidental death and disability insurance; parental leave; remote stipend; learning and development budget; and access to global collaboration tools and resources.