QA Manager, QMS & Compliance – Biotech RUO

GenScript Biotech Corp.

Washington (District of Columbia)

On-site

USD 100,000 - 120,000

Full time

5 days ago

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Benefits offered by this job

Free meals during shift

Onsite massages

Onsite gyms

Job summary

GenScript Biotech Corp is seeking a QA Manager to lead the strategic development and operation of the Seattle site's ISO 9001-certified Quality Management System (QMS). The role covers qualification, quality systems maintenance, raw material management, product release, deviation and CAPA handling, change control, and cross-site quality leadership across multiple production lines and R&D teams.

The position reports to the Senior Vice President of the Innovation Center and requires a Master's

Qualifications

Master's degree in life sciences with 5+ years QA/QC experience in biotech production.
Experience with molecular biology product manufacturing or formulation services is highly desirable.
Lead Auditor training or deep knowledge of ISO 9001:2015 standards.

Responsibilities

Lead and manage the site's QA/QMS to ensure ISO 9001 compliance across production lines, QC groups, and R&D teams.
Oversee facility/utility/equipment qualification, raw material management, product release, deviation and CAPA management, change control, and risk management.
Host and respond to customer audits and ISO surveillance audits; negotiate and manage Customer Quality Agreements (CQAs).
Partner with R&D for tech transfer and ensure timely review of SOPs, reports, and risk assessments.