# Manager of Quality Assurance

**Company**: GenScript Biotech Corporation
**Location**: Redmond, Washington
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Salary**: $100,000 – $120,000 total compensation, including bonus, depending on experience and qualifications
**Category**: Operations
**Industry**: Healthcare

**Apply**: https://job-boards.greenhouse.io/genscript/jobs/5199844007?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_577ec605-9cd

## Description

We are seeking a Manager of Quality Assurance to lead the strategic development and operational management of our site's ISO 9001-certified Quality Management System (QMS).

The successful candidate will be responsible for ensuring consistent and harmonized execution of quality systems across multiple production lines, QC groups, and R&D teams.

Key responsibilities include:

- Developing the QMS strategy and establishing quality procedures to support RUO production and R&D activities

- Leading and hosting customer audits and ISO 9001 surveillance audits

- Managing the site's supplier qualification lifecycle

- Negotiating and managing Customer Quality Agreements (CQAs)

- Partnering with R&D teams to support new technology development and tech transfer

- Providing cross-site quality leadership for QMS lifecycle maintenance, raw material management, and final product release

- Applying Quality by Design principles to define robust control strategies for manufacturing processes

- Overseeing and managing the execution of quality systems during daily production activities

- Presenting updates to project or upper management teams on progress and enforcement of quality improvement and manufacturing support activities

Requirements:

- Master's degree in a life sciences-related field with 5+ years of QA/QC experience in a biotech production environment

- Experience with molecular biology product manufacturing (oligonucleotides, synthetic gene, mRNA) or formulation services is highly desirable

- Completed Lead Auditor training or deep working knowledge of ISO 9001:2015 standards

- Extensive experience hosting external customer audits and filling out supplier quality questionnaires

- Experience drafting and negotiating Quality Agreements with clients

- Expert knowledge of quality risk assessment, CAPA management, and change control methodologies

- Proven track record in establishing or optimizing a quality organization and working collaboratively with R&D, production, and QC groups

Benefits:

- Medical, dental, and vision insurance

- 401(k) & Retirement Savings Plan (RSP)

- Short Term Disability Insurance

- New Child Leave

- Paid Time Off

- Paid Company Holidays per year

- Paid Sick Days (earned based on hours worked)

- Compassionate Leave

- Jury Duty Leave

- Float day

- Personal days

- Free colleague meals during shift

- Onsite massages

- Onsite gyms

## Skills

### Required
- QA/QC
- ISO 9001
- Quality Management System
- supplier qualification
- Customer Quality Agreements
- Quality by Design

### Nice to have
- molecular biology product manufacturing
- Lead Auditor training
- quality risk assessment
- CAPA management
- change control methodologies

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Source: [Apply at job-boards.greenhouse.io](https://job-boards.greenhouse.io/genscript/jobs/5199844007?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)