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Senior Director, Quality Assurance

Company: Surrozen
Location: South San Francisco
Posted on: June 7, 2021

Job Description:

Surrozen is a biotechnology company focused on discovering and developing novel regenerative medicines with a focus on unlocking the powerful self-renewal properties of the body through specific control of the Wnt signaling pathway.

Surrozen was founded by five leading-edge scientists: K. Christopher Garcia, Ph.D., Roel Nusse, Ph.D. and Calvin Kuo, M.D., Ph.D. from Stanford University; Claudia Janda, Ph.D. from the Princess Maxima Center for Pediatric Oncology; and Hans Clevers, M.D, Ph.D. from the Hubrecht Institute and Princess Maxima Center in the Netherlands. Each has conducted extensive research on Wnt signaling, with findings that together shape Surrozen's technology and approach to therapeutic development.

Position Summary

Reporting to the Chief Medical Officer, the Senior Director, Quality Assurance will provide compliance leadership to ensure GCP/GLP/GMP (GxP) compliance across all Surrozen projects.

Additionally, the position will be responsible for implementing clinical and quality compliance plans to include external GCP and GMP audits of clinical services providers, CROs, contract manufacturing organizations (CMOs), suppliers, and investigator sites, as well as internal audits of clinical processes and procedures. This role will partner with Clinical Operations for all the GCP systems and activities, and with Technical Operations (CMC) in establishing a cross functional Quality Team. This role is instrumental in providing oversight to integrate quality throughout all steps of the GCP, GLP and GMP processes, monitoring and auditing using risk assessments and tracking key metrics to drive improved compliance and quality of the GXP activities.

Responsibilities

  • Formulate GCP, GLP and GMP compliance strategy and provide advice for all programs within Surrozen
  • Capable of collaboratively engaging with Contract Organizations
  • Assess GCP, GLP and GMP compliance risk areas and develop and implement risk mitigation measures
  • Develop and prioritize an audit strategy for all programs
  • Plan and lead GCP, GLP and GMP compliance audits including clinical investigator sites, CROs and CMOs to determine compliance status and identify compliance risks
  • Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented and documented
  • Partner with Clinical Development, Clinical Operations, Technical Operations (CMC), Nonclinical, and Regulatory Affairs stakeholders regarding compliance issues and provide compliance guidance to audited parties to encourage process improvement
  • Provide guidance, interpretation and information on GCP, GLP and GMP regulations, standards and quality systems
  • Manage QA reviews of projectrelated of essential clinical study and technical documents
  • Manage regulatory authority inspections and the coordination of responses to resolve inspection findings, if any
  • Develop and implement standards, policies, and procedures for regulatory compliance
  • Develop and implement a GXP training program
  • Establish and maintain Quality Systems
  • Report and escalate compliance issues to management, including requests for directed audits
  • Participate in quality and compliance improvement initiatives
  • Participate in the evaluation and selection of CROs and other service providers as needed
  • Prepare internal QA reports, and provide input for external partners reports and/or regulatory filings
  • Act as the primary business partner with internal Development organization including Clinical Operations, Clinical development, CMC, Nonclinical, and Regulatory
  • Act as the primary contact for vendors, contract facilities and contract service providers
  • Accountable for the QA review of documentation submitted to regulatory agencies

Keywords: Surrozen, South San Francisco , Senior Director, Quality Assurance, Other , South San Francisco, California

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