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, and ...

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, i...

The role will ensure consistent execution of quality systems across the Seattle site covers multiple production lines, QC groups, and R&D teams.

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.
Medical Insurance/ Vision Insurance/ Dental 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