Director, Quality

Company Description

Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to improve the lives of patients with serious diseases. Our industry-leading drug discovery platform, which includes comprehensive proprietary libraries of the extracellular proteome and differentiated screening capabilities, has led to a pipeline comprising five development programs in clinical trials across multiple indications in 2019. We also have several undisclosed research programs that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process using our proprietary screens to discover new immuno-oncology targets.

Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. We value our culture of openness, collaboration and productivity. Discover more about FivePrime at www.fiveprime.com.

Job Description

Five Prime seeks an experienced Quality professional who will lead Five Prime's Quality function and report to the Chief Strategy Officer of Five Prime. The Director of Quality will lead the overall quality strategy for Five Prime and be responsible for oversight and development of all aspects of Quality at Five Prime, including quality oversight of GMP, GCP and GLP systems, processes and activities. The general responsibilities and qualifications of the position are summarized below.

Responsibilities

• Role model and partner with functional leaders to continue to develop a culture of quality to ensure operational excellence at Five Prime
• Develop and implement quality strategy, annual quality plans, department goals and objectives and budgets to achieve quality objectives
• Manage quality talent, including recruitment, selection, development, training and retention of Quality staff and management of consultants and other external resources
• Participate in the qualification of GMP, GCP and GLP service providers
• Lead the quality oversight of contract manufacturing organizations (CMOs), contract research organizations (CROs), lab service providers and other entities performing GXP-related activities on Five Prime's behalf
• Develop and implement risk-based audit plans to assure effective oversight of internal and external GXP activities
• Establish quality agreements with CMOs and CROs
• Collaborate with Five Prime's development partners to ensure effective coordination of quality activities
• Develop and manage a fit-for-purpose Quality Management System
• Develop and implement a roadmap to "inspection readiness"
• Develop corrective and preventive action (CAPA) systems and processes to drive continuous improvement
• Oversee GMP-related quality activities relating to drug substance and drug product manufacturing and supply chain management, including batch record reviews, drug product release (including QP release), deviation investigations and management, tech transfer activities and qualification of CMOs
• Serve as the quality subject matter expert keeping current with GXP compliance matters and industry practices and trends
• Lead Five Prime's GXP Compliance Council, comprised of leaders from relevant departments within Five Prime tasked with high level oversight and review of quality and compliance with respect to Five Prime's GXP activities
• From time to time, present on the status, plans, objectives and metrics of quality at Five Prime to the Executive Team and other governance bodies at Five Prime and, occasionally, to the Nominating and Corporate Governance Committee of the Board

Qualifications

• Bachelor of Science degree in a science related field
• At least 10 years of relevant experience in roles of increasing responsibility
• Significant knowledge of quality assurance and GMP, GCP and GLP regulations
• Experience in managing and providing quality oversight of outsourced GXP-related activities, including qualifying vendors and developing and implementing audit plans
• Hands-on experience developing, implementing and managing quality systems
• People management experience
• Excellent verbal and written communication and interpersonal skills.
• Excellent negotiation, problem solving, decision making and conflict management skills
• Strong ability to influence without direct authority
• Ability to travel from time to time (e.g., for audits, qualification visits and meetings with collaboration partners)

Additional Information

At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.

FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.