Position: Quality Assurance (QA) Lead (Part-Time, Fixed-Term)

Hybrid: Remote & On-site (Ottawa, ON)

Part-time: (2-3 days/week, 6-12 month fixed term, with potential to extend or transition to full-time)

About Yellowbird Diagnostics:

Yellowbird Diagnostics is an early clinical-stage company developing next-generation imaging agents to improve early diagnosis of diseases affecting the brain, heart, and kidneys. Our lead asset is advancing toward first-in-human clinical trials. We are building a quality-driven, science-forward culture, and are seeking a hands-on QA Lead to help develop, maintain, and expand the systems needed to support clinical manufacturing and regulatory compliance.

Position Summary

The QA Lead will be responsible for owning and advancing Yellowbird's Quality Management System (QMS), supporting GMP manufacturing activities, overseeing document control, deviations, and change controls, and ensuring compliance with applicable regulatory standards (Health Canada, FDA, ICH guidelines).

This is a hands-on, collaborative leadership role ideal for someone who thrives in an entrepreneurial, science-driven environment and enjoys building quality systems that scale with growth.

Key Responsibilities

• Maintain, implement, and improve QMS documentation (SOPs, forms, logs, records) in compliance with GMP requirements
• Oversee document control, change control, deviation, CAPA, and training record systems
• Review and approve manufacturing batch records, analytical test results, and equipment qualification documents
• Participate in internal audits and vendor qualification activities
• Assist with preparation for regulatory inspections and submissions (e.g., CTA, IND filings)
• Support ongoing QA oversight of manufacturing, testing, and stability studies
• Provide practical, risk-based QA guidance to operational and scientific teams
• Help identify and implement continuous improvements to QA and QC processes

Qualifications

• Bachelor's degree in a scientific discipline (chemistry, biology, life sciences, or related field)
• Minimum 3 years of QA experience in a GMP-regulated environment (pharma, biotech, or diagnostics)
• Strong experience with document control, deviations, CAPAs, change management, and GMP manufacturing oversight
• Familiarity with Health Canada and FDA regulatory expectations
• Experience working independently in small teams and managing quality systems hands-on
• Candidates with combined QA and QC experience, and/or experience in pharmaceutical, small molecule, or chemistry-driven manufacturing environments are strongly preferred
• Strong organizational skills, attention to detail, and a pragmatic approach to quality
• Experience with early-stage or clinical-stage companies is a strong asset
• Experience supporting radiopharmaceutical or imaging agent development is an asset but not required

Why Join Yellowbird?

At Yellowbird, you'll have the opportunity to build quality systems that matter, influence the direction of an emerging biotech company, and help bring life-changing diagnostic imaging dyes to patients. We offer flexibility, autonomy, and the chance to grow alongside the company.

We value collaboration, respect, integrity, and diligence. We are building a culture where team members are placed in positions to achieve success, make an impact, and drive meaningful change. We believe that great science happens when people are empowered, supported, and trusted to deliver at the highest level.

Additional Details

Compensation commensurate with experience. Flexible structure available for the right candidate.

We are excited to meet mission-driven candidates who are ready to help shape the future of diagnostic imaging!