Associate Director/Director, Quality Systems

Associate Director/Director, Quality Systems

Mountain View, CA

THE POSITION

Associate Director/Director, Quality Systems will play a critical role in setting the strategic direction of the Global Quality Management System. The Associate Director/ Director, Quality Systems will provide key guidance and direction for the implementation of that strategy and realization of the Quality Systems across the full product development lifecycle. The incumbent will have a key role on the Quality Leadership Team and direct interaction with internal partners, global partners, and Regulatory/Quality consultants.

As the leader accountable for the Quality Systems, the incumbent will provide direction and guidance to the functional team in the establishment of work products, priorities, and career development.

PRIMARY POSITION RESPONSIBILITIES

• Define and establish the structure of the Quality Management System, including the supporting tools and organizational interfaces.
• Provide technical SME direction related to the implementation and realization of the Quality Systems, including Documentation, Records Retention, Training, Deviation, CAPA, Change Control, Computer System Assurance/Validation, Product Quality Reviews, and Product Complaints.
• Oversee the implementation of the eDMS and supporting processes.
• Oversee the implementation of the eLMS and supporting processes.
• Establish Inspection Readiness activities and metrics as well as serve as a key inspection host in addition to being the primary point of contact for Quality Systems during audits and inspections.
• Collaborate with the Japanese organization to establish clear and seamless Quality Systems and processes that reflect the global nature of the organization.
• Establish and facilitate the Quality Council and its activities relative to the Management Review.
• Conducts the Management Review including development and reporting of appropriate metrics related to the Quality Management System.
• Lead the Quality Systems team and establish goals, priorities, success criteria, and career development plans.
• Establish and adhere to functional area budget, including the identification and allocation of capital expenditures and resource needs.

QUALIFICATIONS & KEY ATTRIBUTES:

• Bachelor's degree in scientific or related discipline
• 8+ years of Quality experience in the biotechnology, pharmaceutical, or cellular therapy industry with a minimum of 2 years in Quality Management, preferably Quality Systems
• Direct experience with cell and/or gene therapy products or cell culture is a plus
• Prior experience in interaction with Global Health Authority reviewers/investigators and pre-submission meetings
• Working knowledge of global regulations and standards, including FDA, EMA, ICH, and PMDA
• Experience in a virtual company overseeing with Contract Manufacturing Organizations and Contract Testing Laboratories
• Ability to collaborate in a multinational environment to achieve shared goals and objectives
• Experience in sterile medical or combination device products is a plus
• Excellent technical writing skills
• Ability to build teams and manage direct reports
• Strong problem-solving, risk assessment, and impact analysis abilities. Lean Six Sigma training is a plus.
• Proficient with MS Office applications required
• Experience with VeevaVault is a plus