QA Manager, GCP
Posted on Sep 13, 2021 by Seres Therapeutics, Inc.
The Manager, GCP QA will be responsible for conducting GCP QA activities. Reporting to the Director of GCP QA, this individual will have responsibility for QA oversight of GCP activities at Seres, its contract research organizations (CROs) and Investigator Sites to ensure that outsourced third parties (CROs and other GCP service providers) are compliant and prepared for potential Sponsor and Regulatory Inspections and to ensure that the appropriate processes, systems and activities are in place and performed to protect the rights, safety and welfare of our clinical patients. This individual will also oversee, assess and directly work to continuously improve GCP quality processes and to support the state of GCP compliance at Seres. This person will manage cross functional relationships with internal and external stakeholders and be the Quality Assurance representative to clinical teams. This individual will be hands on with internal and external partners.
What You'll Do
Contribute to the development, implementation, and maintenance of GCP Quality Systems and SOPs
Provide consultation in interpretation of regulations/guidelines, as they apply to GCP practice, awareness of regional regulatory requirement, and phase of study
In partnership with the Clinical Operations and other impacted functional areas contribute to the design and implementation of a risk-based clinical Quality Assurance management system
Identify QA and compliance related issues and implement solutions to ensure timelines are maintained
Assist with establishing metrics and reporting the state of GCP Quality and compliance of clinical trials to senior management
Support clinical quality oversight activities for multiple programs within Clinical Development
Assist with preparations for GCP inspection-readiness at Seres, CROs and investigator sites.
Assist with managing GCP Inspections of Seres
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
Assist and/or oversee consultant mediated audits; develop, recommend, and follow up on corrective actions
Assure through audits that GCP supporting vendors, clinical CROs, clinical sites and supporting services are operating in compliance with the Company's quality program, regulations/guidelines and SOPs and are acceptable for performing clinical studies and related services
Manage development of risk-based auditing schedules
What You'll Bring
A Bachelors Degree (or higher) or an MS (or PhD) in a clinical/medical science is strongly preferred. Relevant professional certifications are a plus.
6+ years of relevant industry experience in Sponsor companies, CROs, or GCP consulting
Experience in supporting Regulatory Authority GCP Inspections; supporting BIMO inspections is preferred
Continue to develop experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including applicable GxP auditing