Senior QA, Supplier Quality - Remote & Compliance Lead

SAb Biotherapeutics, Inc.

Canada

Remote

CAD 90,000 - 130,000

Full time

3 days ago
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Job summary

SAB BIO is seeking a Sr. QA Specialist – Supplier Quality to lead third-party qualification, audits, and ongoing quality oversight from suppliers to CDMOs. The role drives cGMP compliance, supports investigations, and mentors junior staff in a biotech setting.

The ideal candidate has 5+ years in QA within regulated manufacturing, hands-on auditing of GMP suppliers, and strong communication. Travel up to 50% and collaboration across functions are essential.

Qualifications

  • BS/BA in life sciences required.
  • 5+ years of quality assurance experience in a regulated manufacturing environment.
  • Hands-on experience qualifying, auditing, and overseeing GMP suppliers and service providers.
  • Experience qualifying GLP and GCP service providers.
  • Strong communication skills and proficiency in Microsoft Office.
  • Ability to present information effectively in various settings.
  • Aseptic gowning on the QA floor when needed.
  • Familiar with eQMS functionality and implementation benefits.
  • Demonstrates self-motivation and accountability for priorities.

Responsibilities

  • Lead risk-based qualification and requalification of third parties through assessments, audits, and recommendations.
  • Manage ongoing third-party quality oversight including performance monitoring, quality agreements, change notifications, and CAPA follow-up.
  • Maintain third-party qualification records and timely reviews.
  • Plan and conduct third-party audits; prepare reports and close follow-ups on corrective actions.
  • Oversee QA for manufacturing and QC operations, including batch record review and deviations.
  • Present quality metrics and training initiatives to leadership.
  • Drive quality systems ownership: change control, CAPA, document management.
  • Author, review, and approve SOPs, batch records, and work instructions.
  • Perform batch disposition activities with review of records and COAs.
  • Inspect and approve raw materials and components against specifications.
  • Provide QA floor support during manufacturing.
  • Other duties as assigned.

Skills

Quality assurance
Auditing
Communication
Presentations
Gowning aseptically
eQMS familiarity
Data analysis

Education

BS/BA in life sciences

Tools

Microsoft Office
eQMS

Job description

SAB BIO is seeking a Sr. QA Specialist – Supplier Quality to lead third-party qualification, audits, and ongoing quality oversight from suppliers to CDMOs. The role drives cGMP compliance, supports investigations, and mentors junior staff in a biotech setting.

The ideal candidate has 5+ years in QA within regulated manufacturing, hands-on auditing of GMP suppliers, and strong communication. Travel up to 50% and collaboration across functions are essential.

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