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.
The Quality Systems Inspection Lead will support Orca Bio in ensuring our newly built commercial facility (in Sacramento, CA) is ready for prior approval inspection of our lead candidate, Orca-T. This role will help to build the internal and external site audit programs and will assist in preparation of the facility for PAI (Pre-Approval Inspection) readiness.
Responsibilities
·Establish and maintain the facility internal audit program
·Perform internal audit activities and external audits upon request
·Establish SME training in support of Regulatory Inspections
·Perform SME training and practice sessions
·Establish backroom audit tools and manage audit backroom during regulatory inspections
·Support other facility quality systems time permitting
General Requirements
·Communicate effectively with team members and contribute to a positive and collaborative work environment
·Actively participate in group and project teamwork; project and process improvements
·Strong organizational skills and the ability to manage multiple tasks concurrently
·Willingness to learn and adapt in a fast-paced, dynamic environment
·Adhere to cGMP policies and procedures, including documentation activities
Desired Experience
·Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 5-10 years of experience in quality systems and supporting regulatory inspections
·Have lead or participated in multiple regulatory inspections and served on "audit team" for an FDA inspection
·Experience preparing SMEs for FDA inspection, including developing training tools and running the "back room" during an FDA inspection
·Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred
·Reliably able to contribute to decision making in areas of expertise
·Able to lead project and testing timelines
·Detail-oriented with a strong commitment to data integrity and accuracy, with ability to identify and solve problems with data management
·Adaptable and responsive to changing priorities and challenges
·Ability to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment
The anticipated annual salary for this U.S. based job is $100,000– $130,000. The final offer will be based on professional experience previously in this role/industry, education, geographic location, internal equity, and other job-related factors as permitted by law. For remote-based candidates, this range may vary based on your local market. Actual compensation may vary. You will also be eligible to receive pre-IPO equity, in addition to medical, dental, vision, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Total compensation will be determined at the Company’s sole discretion.
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.
