Manager of Quality Assurance

About GenScript 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, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions. The 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 is accountable for ensuring 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 will ensure consistent execution of quality systems across the Seattle site covers multiple production lines, QC groups, and R&D teams. Based on corporate policies, develop the QMS strategy and establish quality procedures to support RUO production and R&D activities at the Seattle site. Customer & ISO Audits: Lead and host frequent customer audits and ISO 9001 surveillance audits. Act as the primary face of Quality for the site, effectively demonstrating the robustness of our QMS to external partners Supplier Qualification: Manage the site's supplier qualification lifecycle. Evaluate, approve, and continuously monitor external providers of raw materials and services through questionnaires, audits, and performance tracking to ensure ISO 9001 compliance. Customer Quality Agreements: Negotiate and manage Customer Quality Agreements (CQAs) and efficiently handle customer supplier questionnaires, ensuring alignment between client expectations and our RUO manufacturing standards. R&D and Tech Transfer: Partner with the R&D teams to support new technology development, ensuring seamless tech transfer. Review and approve R&D SOPs, reports, and risk assessments promptly to maintain the agility required for RUO environments without creating bureaucratic bottlenecks. 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 the 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 r…