Position Summary:

The Senior Manager, 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 will oversee product disposition, 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. The ideal candidate will have a strong working knowledge of relevant FDA, EU, ICH GMP, guidelines, and GMP regulations and experience working with CMOs and CTLs.

This role will report to the Senior Director of Quality Assurance and will work closely with key stakeholders including CMC, Regulatory Affairs, and Project Management. This is a high visibility position that will play a key role in partnering with our parent company, Otsuka Pharmaceutical.

Duties and Responsibilities

• Provide oversight of external contract manufacturing, testing, and research organizations including on-site visits during Visterra activities and business review meetings
• Responsible 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
• Lead investigations into quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness
• Assist in the further development of the Visterra Quality Management System, including Quality Plans, metrics to monitor effectiveness, and management reviews
• Develops or monitors metrics (KPI's) for all Quality Operations regarding Management Review
• Represent quality on project teams, as needed and provide GMP compliance
• Perform review of documents and subsequent document revisions for internal and external Quality groups
• Provide guidance and support with resolution of investigations, CAPAs, Change Controls, and other applicable Quality Events impacting clinical materials
• Maintain contemporary knowledge of current industry trends and methodologies as relevant to GxP practices
• Foster Visterra core values when collaborating with cross functional teams and external partners
• Other duties and responsibilities as dictated by departmental and business needs
• Work to further develop and imbue a Quality culture

Education/Skills and Experience Requirements

• Bachelor of Science degree or BA combined with relevant work experience
• Minimum of 8 plus years in related biopharmaceutical Quality Operations roles
• Previous experience managing external contract organizations required
• Previous experience with Veeva QualityDocs and ComplianceWire preferred
• Leadership, negotiation, and conflict management skills
• Excellent organizational and time management skills with a high level of attention to detail
• Strong interpersonal, organizational, and multi-tasking skills

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.

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 110 employees and is located in Waltham, Massachusetts.

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.