Associate Director Quality Assurance

Profile

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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Visterra is a wholly owned subsidiary of Otsuka America, Inc., which is a U.S. holding company and a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan. Visterra has approximately 85 employees and is located in Waltham, Massachusetts.

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Summary

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The Associate Director, Quality Operations will play a lead role in the further development and management of GMP Quality Operations at Visterra in accordance with applicable global regulatory requirements and Visterra business objectives. This role, reporting to the Director, Head of Quality Assurance, will oversee batch record review, and approval of manufacturing operations while supporting the implementation of scalable QA processes. The primary objective is to ensure manufacturing processes are capable, compliant, in control, and continuously improved. This is a high visibility position that will play a critical role in partnering with our affiliated company, Otsuka Pharmaceutical.

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This is a full-time position based in Visterra’s facility in Waltham, MA. 

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Responsibilities

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• Own the responsibility for clinical batch disposition. Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition.
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• Serve as the Quality lead to support product Risk Assessments, supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions.
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• Review and approve quality events such as deviations, CAPA, and Change Control, performing Failure Mode and Effect Analyses, root cause analyses, and CAPA effectiveness check, as required.
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• Develop, monitor, and improve quality processes, ensuring scalability and sustainability to meet the growing needs of the organization.
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• Assist in developing Quality Plans and metrics to monitor QMS effectiveness and communicating results to senior management via management review.
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• Foster a quality mindset throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions.
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• Lead the management review of quality compliance and operational key performance indicators to ensure the identification and timely mitigation of unfavorable trends.
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• Provide strategies to address compliance gaps or determine enhancements to cross-functional quality systems.
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• Work to develop and imbue a Quality Culture across the organization.
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• Effectively communicate and meet deliverables and timelines.
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• Maintain contemporary knowledge of current industry and quality trends, standards, and methodologies.
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• Other duties and responsibilities as required by departmental and business needs.
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Requirements

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• A minimum of 10 years of experience in related Biopharmaceutical Quality Operations or Compliance roles, with at least 6 years of experience in Quality Operations.
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• A BA or BS is preferred though long-time experience in QA may be acceptable.
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• Strong interpersonal and organizational skills, and attention to detail.
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• The ability to provide subject matter expertise regarding GxP operations and CMO management.
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• Strong leadership skills with the ability to thrive in a high throughput environment.
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• Ability to lead and manage projects and teams within corporate objectives and project timelines.
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• Previous experience with CMO management, Veeva QMS, and ComplianceWire.
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• Entrepreneurial and results driven mindset, and the ability to work with little instruction.
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• Travel up to 15% of the time may be required to attend meetings, conferences, and industry events.
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Visterra provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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Company info

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