Manager of Quality Assurance

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

About the role

This position reports to the Senior Vice President of the Innovation Center and is responsible for the strategic development and operational management of the site’s ISO 9001-certified Quality Management System (QMS). The QA Manager ensures consistent and harmonized execution of quality systems, including facility/utility/equipment qualification, quality systems establishment and maintenance, raw material management, production process support, product release, deviation and CAPA management, change management, and risk management across the Seattle, WA site. The role covers multiple production lines, QC groups, and R&D teams.

Responsibilities

• Develop the QMS strategy and establish quality procedures to support RUO production and R&D activities at the Seattle site based on corporate policies.
• Lead and host frequent customer audits and ISO 9001 surveillance audits, acting as the primary face of Quality for the site.
• Manage the site's supplier qualification lifecycle, evaluating, approving, and continuously monitoring external providers of raw materials and services to ensure ISO 9001 compliance.
• Negotiate and manage Customer Quality Agreements (CQAs) and handle customer supplier questionnaires, ensuring alignment between client expectations and RUO manufacturing standards.
• Partner with R&D teams to support new technology development and ensure seamless tech transfer, reviewing and approving R&D SOPs, reports, and risk assessments.
• Provide cross-site quality leadership for QMS lifecycle maintenance, raw material management, final product release, supply chain, automation, manufacturing, validation, and facility engineering across all 3 production lines.
• Apply Quality by Design principles to define robust, integrated control strategies for oligonucleotide, synthetic gene, mRNA, and formulation manufacturing processes.
• Oversee and manage the execution of quality systems during daily production activities to ensure the delivery of high-quality RUO molecular biology products.
• Present updates to project or upper management teams on progress and enforcement of quality improvement and manufacturing support activities.

Qualifications

• Master’s degree in a life sciences-related field (or equivalent) with 5+ years of QA/QC experience in a biotech production environment, including substantial management responsibility.
• Experience with molecular biology product manufacturing (oligonucleotides, synthetic gene, mRNA) or formulation services is highly desirable.
• Completed Lead Auditor training or possesses deep working knowledge of ISO 9001:2015 standards.
• Extensive experience hosting external customer audits and filling out supplier quality questionnaires in a B2B life sciences or CRDMO environment.
• Experience drafting and negotiating Quality Agreements with clients, with a strong ability to manage customer expectations appropriately for an RUO setting.
• Expert knowledge of quality risk assessment, CAPA management, and change control methodologies within an RUO or ISO-certified manufacturing environment.
• Proven track record in establishing or optimizing a quality organization and working collaboratively with R&D, production, and QC groups.
• Excellent diplomacy, negotiation, and customer-service skills, with the ability to confidently explain and defend quality systems to technical and quality representatives from partner organizations.
• Strong interpersonal, verbal, and written communication skills.

Pay

Salary range: $100,000 – $120,000 total compensation, including bonus, depending on experience and qualifications.

Benefits

• Medical, vision, and dental insurance.
• 401(k) & Retirement Savings Plan (RSP) with a company match that vests fully on day one.
• Paid parental leave after three months of employment.
• Paid time off policy including vacation time, personal time, sick time, floating holidays, and company holidays.
• Flexible spending and health savings accounts.
• Life and AD&D insurance, short- and long-term disability coverage.
• Legal assistance and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• Commuter benefits, well-being initiatives, and peer-to-peer recognition programs.

Perks

• Free colleague meals during shift.
• Onsite massages.
• Onsite gyms.