Senior Specialist Global QMS

Orca Bio · Job · via RemoteOK

Type
Job
Organization
Orca Bio
Location
Remote
Deadline
Rolling or not stated
Remote
Yes
Who can apply
Not stated
Posted
22 August 2026

Apply — via RemoteOK

About this Opportunity

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.

Eligibility

  • Bachelor’s degree in a scientific or engineering discipline required; advanced degree preferred.
  • Minimum 5+ years of relevant Quality Assurance or Quality Systems experience in a GxP-regulated environment, with at least 2-3 years in a leadership role.
  • Strong knowledge of global quality regulations and standards (FDA, EMA, ICH, ISO 9001, 21 CFR Parts 210/211/820, EU GMP).
  • Proven experience leading Quality Management Review, internal audit programs, supplier management processes, and validation oversight.
  • Demonstrated success in establishing and trending quality performance metrics and KPIs.
  • Experience supporting and/or administering electronic QMS systems and partnering with IT for system enhancements.

Documents you may need

  • Updated CV / Resume
  • Cover Letter (tailored to this role)

How to apply

  1. Click the "Apply — via RemoteOK" button to go to the source page.
  2. Read the full description and confirm you meet the requirements.
  3. Prepare your CV and cover letter tailored to this role.
  4. Submit your application through the official portal.
  5. Follow up within 1–2 weeks if you do not hear back.

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