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Associate Director, GCP Quality Assurance

2 months ago

Remote, Oregon, United States Orca Biotech Full time

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

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 lead inspection preparedness and be heavily involved in the inspections. 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 to prepare the company for regulatory inspections. 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.
  • 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.) and CSR audits.

Qualifications

  • Bachelor's degree is required (preferably in a scientific discipline) with 10+ years' experience in Quality Management related to GCP.
  • Cell therapy experience preferred.
  • Prior 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 who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask "why not" and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

To learn more:

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 team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.