Quality Assurance Director – ISO & Compliance Leader

GenScript Biotech Corp.; Redmond (WA); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company-m/

Parental leave

Paid Time Off

Job summary

GenScript Biotech Corp. in Seattle, WA is seeking a QA Manager to lead the strategic development and operation of the site’s ISO 9001-certified Quality Management System. You will drive audits, supplier qualification, and risk management across multiple production lines, QC groups, and R&D teams.

You will collaborate with R&D for tech transfer, ensure CQAs, and apply Design by Quality to critical RUO manufacturing processes. Strong leadership and GMP-like mindset are essential.

Qualifications

• Master’s degree in a life sciences-related field with 5+ years of QA/QC experience in biotech production environments.
• Experience with molecular biology product manufacturing or formulation services is highly desirable.
• Lead Auditor training or deep knowledge of ISO 9001:2015 standards.
• Experience hosting external customer audits and completing supplier quality questionnaires in a B2B life sciences or CRDMO setting.
• Experience drafting and negotiating Quality Agreements with clients in RUO settings.
• Strong knowledge of quality risk assessment, CAPA management, and change control methodologies.

Responsibilities

• Develop the QMS strategy based on corporate policies to support RUO production and R&D at the Seattle site.
• Lead customer and ISO audits and act as the primary face of Quality for the site.
• Manage supplier qualification lifecycle and monitor external providers for ISO 9001 compliance.
• Negotiate and manage Customer Quality Agreements and supplier questionnaires.
• Support R&D and tech transfer, review SOPs, reports, and risk assessments.
• Provide cross-site quality leadership for QMS lifecycle maintenance across production lines, QC, and R&D teams.
• Apply Quality by Design principles to define robust control strategies for oligonucleotide, synthetic gene, mRNA, and formulation processes.
• Oversee daily production quality system execution to ensure high-quality RUO products.

Skills

QA/QC

Lead Auditor

Regulatory compliance

Audits & CQAs

CAPA & change control

R&D collaboration

Education

Master’s degree in life sciences

Job description

GenScript Biotech Corp. in Seattle, WA is seeking a QA Manager to lead the strategic development and operation of the site’s ISO 9001-certified Quality Management System. You will drive audits, supplier qualification, and risk management across multiple production lines, QC groups, and R&D teams.

You will collaborate with R&D for tech transfer, ensure CQAs, and apply Design by Quality to critical RUO manufacturing processes. Strong leadership and GMP-like mindset are essential.