QA Manager, Biotech Quality & Compliance

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

Benefits offered by this job

Medical Insurance

401(k) Plan

Paid Time Off

Onsite Gym

Job summary

GenScript Biotech Corp. is seeking a QA Manager to lead the Quality Management System for the Seattle site, ensuring ISO 9001 compliance across multiple lines and functions, including R&D, QC, and production.

The role focuses on audits, supplier qualification, CQAs, and risk-based quality improvements, with a strong emphasis on collaboration with R&D and manufacturing teams to support RUO development and tech transfer.

Qualifications

• Master’s degree in life sciences required or equivalent.
• 5+ years QA/QC experience in biotech production environment.
• Lead Auditor training or equivalent ISO 9001 knowledge.
• Experience hosting external audits and supplier questionnaires.
• Experience drafting Quality Agreements with clients in RUO/biotech.

Responsibilities

• Develop QMS strategy aligned with corporate policies for Seattle RUO production.
• Lead and host customer and ISO surveillance audits; be the face of Quality.
• Manage supplier qualification lifecycle and monitor external providers.
• Negotiate and govern Customer Quality Agreements (CQAs) and supplier questionnaires.
• Support R&D and tech transfer; review SOPs, reports, and risk assessments.

Skills

QA/QC

ISO 9001

Lead Auditor

Audits

Supplier Qualification

CAPA

Change Control

Risk Management

Education

Master’s degree in life sciences

Tools

QMS software

CAPA tooling

Job description

GenScript Biotech Corp. is seeking a QA Manager to lead the Quality Management System for the Seattle site, ensuring ISO 9001 compliance across multiple lines and functions, including R&D, QC, and production.

The role focuses on audits, supplier qualification, CQAs, and risk-based quality improvements, with a strong emphasis on collaboration with R&D and manufacturing teams to support RUO development and tech transfer.