Over one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease.
Orca Bio's investigational, high-precision cell therapies are designed to replace a patient's compromised blood and immune system with a healthy one, while dramatically lowering the risk of developing life-threatening or debilitating transplant-related side-effects. The first application of Orca Bio's platform is in blood cancer where the unmet need is most acute; with a robust pipeline of promising cell therapies, we plan to extend into autoimmune diseases and genetic blood disorders as well.
To thrive in the role of Associate Director, GCP QA, you will have a strong GCP background with extensive working knowledge of global regulation and standards (FDA focus) and how they apply to the cross-functional departments within the sponsor's organization, vendors, and clinical investigator sites. Regulatory inspection experience is a must as this role will be essential to inspection preparedness and the inspections themselves. Clarity around issue prioritization/escalation is critical as well as GCP CAPA management.
You will be a dependable and informed team member who will collaborate with relevant cross-functional teams (Clinical Operations, Clinical Development, Data Management, Biostatistics, Clinical Supply Chain, PV) to establish/revise Orca Bio SOPs, Work Instructions and other process tools/templates. Additionally, you will fulfill clinical audit needs (vendors and investigator sites; onsite and remote) and must be capable of working autonomously and proactively with minimal direction.
This is a new role, reporting to the Head of Clinical QA.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all patients who need them.
We strive to do things right, and to embody our core values of passion, courage, and integrity. Excellence in our work means the potential to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate daily on a path that hasn't been paved. This means we lean heavily on our entrepreneurial spirit and are comfortable taking calculated risks to achieve progress toward our mission. It means we aren't afraid to ask "why not," and encourage lively discourse around rethinking the status quo.
We work hard to preserve our start-up culture rooted in camaraderie and leadership by example - by everyone, regardless of title.
We're proud to be an equal opportunity employer, and have seen how our differences - when celebrated and woven together - create stronger and more lasting solutions that better serve our team, our partners, and most importantly, our patients and the providers who treat them.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent department, and all candidates are presented through this channel only. We do not accept unsolicited resumes.