GMP Quality Assurance Lead | Biotech & Cell Therapy

Aspect Biosystems; Vancouver; On-site; CAD 74,000 - 92,000; Full time

Benefits offered by this job

Equity

Benefits package

Career progression

Learning & development

Job summary

Aspect Biosystems is seeking a Quality Assurance Specialist to strengthen and oversee quality assurance activities for clinical GMP manufacturing of bioprinted cell therapies. You will develop, apply, revise and maintain quality metrics while driving continuous improvement of manufacturing and quality systems.

You will collaborate with R&D from early development to embed quality standards into product designs, documentation, and engineering processes, and support vendor qualification and change

Qualifications

• Bachelor's or Master's degree in Biology, Biotechnology or related field with 5–7+ years of GMP quality program experience.
• Regulatory knowledge of FDA/EMEA and biologics/pharmaceuticals is required.
• Detail-oriented with strong process discipline and accuracy.
• Go-getter attitude with ability to work in fast-paced, interdisciplinary teams.
• Collaborative mindset to work across R&D, CMC, QC and other groups.

Responsibilities

• Support development of internal QA processes and QMS implementation.
• Maintain and provide document control support.
• Assist in training content for QA processes and maintain training/certification requirements.
• Identify issues in processes and documentation and propose remediation.
• Provide QA expertise on change management and document/process/material changes.
• Collaborate with R&D to embed quality into product designs and engineering processes.
• Support vendor qualification by ensuring documents are up to date and compliant.
• Review study protocols, reports, SOPs, policies, forms and other controlled documents.

Skills

GMP quality programs

Regulatory knowledge

Quality system implementation

Cross-functional collaboration

Education

Bachelor's or Master's in Biology/Biotechnology

Job description

Aspect Biosystems is seeking a Quality Assurance Specialist to strengthen and oversee quality assurance activities for clinical GMP manufacturing of bioprinted cell therapies. You will develop, apply, revise and maintain quality metrics while driving continuous improvement of manufacturing and quality systems.

You will collaborate with R&D from early development to embed quality standards into product designs, documentation, and engineering processes, and support vendor qualification and change