Job Summary

The Director, Quality Systems & Compliance will play a lead role in the further development and management of the Quality Management System at Visterra in accordance with applicable global regulatory requirements and Visterra business objectives. This is a high visibility position that will play a critical role in partnering with our parent company, Otsuka Pharmaceutical.

Responsibilities

• Oversight for companywide GxP training programs, ensuring a clear line of sight from training requirements to specific GxP job functions aligned to job descriptions
• Lead the further development, execution, and maintenance of all aspects of the Visterra (internal and external) audit and inspection readiness programs
• Participate in the continuous improvement of the Visterra inspection readiness program and implementation of additional initiatives
• Develop, review, and ongoing monitoring of quality agreements and associated contracts
• Ownership of the GxP Training, Supplier Management, and GxP documentation systems
• Assist with the execution of the Quality Management Review process, including oversight of analysis and reporting of Quality System and supplier performance metrics
• Ownership of the supplier qualification program, inclusive of audit planning, logistics, and audit execution over the general GxP landscape
• Foster cross-functional collaboration to execute ongoing risk assessments of contracted service providers to ensure accurate classification and handling of suppliers
• Develop, monitor, and improve quality processes which are scalable and sustainable to meet the growing needs of the organization
• Foster a quality mindset throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions
• Assist with presenting the management review of quality compliance and operational KPIs to ensure the identification of and timely mitigation of unfavorable trends

Qualifications

• A minimum of 12+ years of experience in related Biopharmaceutical Quality or Compliance roles
• A BA or BS is preferred though long-time experience in QA may be acceptable
• Strong interpersonal and organizational skills and attention to detail
• Thorough knowledge of Quality Assurance (GxP), Quality Systems, and Compliance to ensure subject safety, data integrity, product quality, and operational compliance
• Qualified auditor status preferred
• Proven experience managing/influencing stakeholders across a broad spectrum of GxP topics
• Proven experience regarding initiating or ownership of inspection readiness initiatives
• Strong leadership skills with the ability to thrive in a high throughput environment
• Ability to lead and manage projects/teams within corporate objectives and project timelines
• Previous Veeva and ComplianceWire experience required
• Ability to travel up to 20% of the time

Company

Visterra is a clinical stage biotechnology company committed to developing innovative biologic therapies for the treatment of kidney diseases, with an immuno-nephrology focus. Our proprietary technology platform enables the design and engineering of precision antibody or protein-based drug candidates to modulate key disease targets. We are developing a robust pipeline of novel therapies for patients with unmet needs.

Visterra is a wholly owned subsidiary of Otsuka America, Inc., which is a U.S. holding company subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan. Visterra has approximately 125 employees, and is located in Waltham, Massachusetts.