Associate Director, GCP Quality Assurance
Remote
Quality – Quality Assurance /
Regular, Full-Time Employee /
Remote
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.
Duties
- Proactively partners with relevant departments to implement compliant procedures and operations to ensure a robust quality management system for both the conduct of clinical studies as well as prepare the company to successfully commercialize clinical products.
- Carries out the organization, preparation, coordination, and documentation of regulatory inspection readiness and serves as a key lead during regulatory inspections. Manages site and vendor preparedness, schedules coaching sessions with internal team members, follows-up on action items, maintains inspection tools.
- Leads the clinical vendor qualification/audit program (maintains the vendor list, plans and schedules audits, conducts audits and generates audit reporting documentation). Leads the investigator site audit program (plans and schedules audits, conducts audits, generates audit reporting documentation, follows up with the site on action items stemming from the audit).
- Participates in the organization, preparation, coordination, and documentation of regulatory inspection readiness and serves as key QA contributor during regulatory inspections. Assists in site and vendor preparedness.
- Assists with providing GCP compliance oversight of internal processes as well as those of CROs, vendors, and investigator sites.
- Serves as the CAPA SME to process CAPAs in Master Control and provide guidance to cross-functional teams to ensure robust management and documentation of issues.
- Reviews and provides input to clinical documentation (ICFs, protocols, etc.).
- Performs Clinical Study Report (CSR) Audits.
Qualifications
- Bachelor's degree is required (preferably in a scientific discipline) with 10+ years' experience in Quality Management related to GCP.
- Extensive experience independently auditing clinical vendors and investigator sites.
- Cell therapy experience preferred.
- Ideally, experience preparing for and hosting audits (sponsor audits); at minimum, participating in regulatory inspections.
- Hands-on leader capable of identifying what needs to be done and translating that into action, often with minimal direction.
- Excellent written and verbal communication skills, time management and organizational skills.
- Strong negotiation and problem-solving skills are a must, to ensure continued respect and cooperation among teams.
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.
