Sr. Manager, Clinical Quality Assurance

Position Summary:

The Clinical Quality Assurance Manager/ Senior Manager will play a lead role in the further development and management of GCP QA activities at Visterra in accordance with applicable global regulatory requirements and Visterra business objectives. This role will oversee all GCP activities conducted by Visterra and Visterra’s Contract Research Organizations (CRO), and Investigator Sites to ensure third party suppliers are compliant with governing regulations and audit ready. The ideal candidate will have a strong working knowledge of relevant FDA, EU, ICH GMP, guidelines, and GCP regulations and experience working with CROs.

This role will report to the Senior Director of Quality Assurance and will work closely with key stakeholders to ensure GCP compliance at Visterra and with Visterra’s contracted suppliers. This is a high visibility position that will play a key role in partnering with our parent company, Otsuka Pharmaceutical.

Duties and Responsibilities:

• Provide compliance support for activities at clinical sites including issue resolution, impact assessment and inspection readiness Provides input to clinical functions to ensure that clinical trial activities sponsored by Visterra are conducted by CROs in compliance with GCP regulations and internal requirements Provide internal audit support related to systems, documents and functions Prepare quality metrics for presentation to management Work directly with CROs and other external suppliers and collaborators, managing the chain of communication related to GCP compliance Attend cross-functional team meetings, provide guidance to different functional groups (including clinical and PV), based on interpretation of current regulations to ensure best practices including risk-based approach Escalate issues of critical non-compliance and/or lack of urgency in remediation to senior Quality management Provide QA review of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports, Investigator Brochures and other relevant documents Provide and/or assist in periodic GCP training to the Visterra staff as necessary Assists in resolving compliance issues at clinical sites, clinical vendors, laboratories, and other suppliers by providing an assessment of the impact of any deficiencies and follow-up of CAPA implementation Implement CAPAs to address critical GCP QA issues Acts as GCP QA Study/Program lead Reviews contracts with clinical suppliers and partners to ensure compliance responsibilities are included Supports the implementation and maintenance of QA systems and SOPs for GCP compliance Support clinical quality oversight activities for multiple programs within Clinical Development Ensure Clinical Development activities are compliant with GCP, FDA, ICH, and other applicable regulations and guidelines and industry standards Review key safety, clinical and regulatory documents, such as DSUR, Protocol, IB, IND and NDA

• 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 7+ years of relevant work experience

• Minimum of 5 plus years of experience in sponsor companies, CRO, or GCP roles Previous experience managing CROs and clinical suppliers required Demonstrated experience leading and/or conducting audits, audit certification preferred but not mandatory. Expertise regarding GCP regulations and regulatory agency expectations and guidance 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 Position Summary:

   

  The Clinical Quality Assurance Manager/ Senior Manager will play a lead role in the further development and management of GCP QA activities at Visterra in accordance with applicable global regulatory requirements and Visterra business objectives. This role will oversee all GCP activities conducted by Visterra and Visterra’s Contract Research Organizations (CRO), and Investigator Sites to ensure third party suppliers are compliant with governing regulations and audit ready. The ideal candidate will have a strong working knowledge of relevant FDA, EU, ICH GMP, guidelines, and GCP regulations and experience working with CROs.

   

  This role will report to the Senior Director of Quality Assurance and will work closely with key stakeholders to ensure GCP compliance at Visterra and with Visterra’s contracted suppliers. This is a high visibility position that will play a key role in partnering with our parent company, Otsuka Pharmaceutical.

   

  Duties and Responsibilities: Provide compliance support for activities at clinical sites including issue resolution, impact assessment and inspection readiness Provides input to clinical functions to ensure that clinical trial activities sponsored by Visterra are conducted by CROs in compliance with GCP regulations and internal requirements Provide internal audit support related to systems, documents and functions Prepare quality metrics for presentation to management Work directly with CROs and other external suppliers and collaborators, managing the chain of communication related to GCP compliance Attend cross-functional team meetings, provide guidance to different functional groups (including clinical and PV), based on interpretation of current regulations to ensure best practices including risk-based approach Escalate issues of critical non-compliance and/or lack of urgency in remediation to senior Quality management Provide QA review of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports, Investigator Brochures and other relevant documents Provide and/or assist in periodic GCP training to the Visterra staff as necessary Assists in resolving compliance issues at clinical sites, clinical vendors, laboratories, and other suppliers by providing an assessment of the impact of any deficiencies and follow-up of CAPA implementation Implement CAPAs to address critical GCP QA issues Acts as GCP QA Study/Program lead Reviews contracts with clinical suppliers and partners to ensure compliance responsibilities are included Supports the implementation and maintenance of QA systems and SOPs for GCP compliance Support clinical quality oversight activities for multiple programs within Clinical Development Ensure Clinical Development activities are compliant with GCP, FDA, ICH, and other applicable regulations and guidelines and industry standards Review key safety, clinical and regulatory documents, such as DSUR, Protocol, IB, IND and NDA 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 7+ years of relevant work experience Minimum of 5 plus years of experience in sponsor companies, CRO, or GCP roles Previous experience managing CROs and clinical suppliers required Demonstrated experience leading and/or conducting audits, audit certification preferred but not mandatory. Expertise regarding GCP regulations and regulatory agency expectations and guidance 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

About Visterra

We are a team of 100 talented and driven people working passionately and collaboratively to develop a robust pipeline of innovative antibody-based therapies for patients with unmet needs. Our proprietary technology platform powered by our state-of-the-art laboratory enables the design and engineering of precision antibody-based product candidates that specifically bind to, and modulate, key disease targets for the treatment of patients with kidney diseases and other hard-to-treat diseases. Visterra is a subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan. As a member of the Otsuka family of companies, we have the advantage of being a dynamic, nimble, innovative organization where you can make direct, meaningful impacts while benefitting from the support, stability, and long-term perspective of a 100-year-old global company.