The position reports to the Vice President of Innovation Center, and is responsible for the strategic development and operational management of site’s QMS (Quality Management System), and is accountable for ensuring consistent and harmonized execution of the 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 Redmond, WA site.

• Based on corporate policies, develop strategy of QMS and establish quality procedures to support production at Redmond, WA site.
• Provide cross-site quality leadership to quality systems lifecycle maintenance, raw material and final product release, supply chain, automation, manufacturing, validation and facility engineering.
• Apply Quality by Design principles to define a robust, integrated control strategies of the mRNA and synthetic DNA manufacturing process.
• Oversee and manage the execution of quality systems during daily production activities to ensure the delivery of high quality products.
• Lead the preparation and execution of regulatory and client inspections, host audits and responsible for corrective action plans.
• Present updates to project or upper management teams on progress and enforcement of quality improvement and manufacturing support activities.
• Review and approve SOPs (Standard Operating Procedures) , reports and risk assessments, and work to improve application and standardization of phase appropriate processes and curricula.

• Master’s degree, ideally in life sciences related field or equivalent with 5+ years of QA/QC experience in biotech production environment with substantial management responsibility within Quality Assurance. Experience with gene and cell therapy products or mRNA products highly desirable.
• Completed Lead Auditor training for any standard (preferably ISO 9001, ISO 13485 and/or relevant regulatory requirements). Prior audit experience is a plus.
• Deep understanding and demonstrated working knowledge of Code of Federal Regulations (CFRs), ICH guidance documents, EudraLex Vol. 4, and other regulations that govern GXP compliance during clinical development and commercialization of drug candidates.
• Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation.
• Proven track record in establishing a quality organization, managing GMP Quality staff a plus.
• Experience in USFDA and ISO auditing and ability to lead team to successful audits.
• Versed in phase appropriate practices of clinical vs. commercial manufacturing requirements.
• Adept in building working relationship between QA and other operating functions.
• Experience in CMC regulatory requirements for FDA and EMA is a plus.
• Strong interpersonal, verbal, and written communication skills.