What are the responsibilities and job description for the Director, Quality Systems & Compliance position at Visterra?
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.
