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Director, Quality Systems & Compliance

Employer
Visterra, Inc.
Location
Waltham, Massachusetts
Start date
Feb 1, 2025
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Job Details

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, onsite position that will play a critical role in partnering with our parent company, Otsuka Pharmaceutical from our Waltham, MA office. 

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
  • Position is based in Waltham and is on-site


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.

Company

Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney diseases and other hard-to-treat diseases. Our proprietary technology platform enables the design and engineering of precision antibody-based product candidates that specifically bind to, and modulate, key disease targets. Applying this technology to disease targets that are not adequately addressed by traditional therapeutic approaches, we are developing a robust pipeline of novel therapies for patients with unmet needs.

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Company info
Website
Phone
6174012031
Location
275 2nd Avenue
Waltham
Massachusetts
02451
United States

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