Senior Director, Quality Assurance

Surrozen

South San Francisco, CA, US
  • Job Type: Full-Time
  • Function: Life Sciences QA/QC
  • Post Date: 05/03/2021
  • Website: surrozen.com
  • Company Address: 240 E. Grand Avenue Second Floor, San Francisco, CA, 94080

About Surrozen

Surrozen is a newly launched biopharmaceutical company founded by world-leading scientists from Stanford University, Drs. Chris Garcia, Roel Nusse, and Calvin Kuo. The company is focused on harnessing the Wnt pathway to identify novel therapeutics for regenerative medicine, leveraging breakthrough insights from its founders in protein engineering, stem cell dynamics, and fundamental Wnt biology. Surrozen is seeking highly creative, motivated, and talented individuals to join its founding scientific team, working to decipher the complex biology that governs the body’s response to damage and discover highly innovative drugs that accelerate the repair and renewal of human tissues.

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 project‐related 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

Requirements

  • Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical), math, engineering, industrial engineering or a related field and 15 years of related experience in the pharma/biotech industry.
  • Minimum of 10 years GCP / GMP Quality Assurance experience
  • In‐depth knowledge of and ability to interpret and apply FDA, EMA and ICH regulations, guidelines, and best practices
  • Experienced in early phases of biologics drug development.
  • Experience in planning and conducting GCP, GLP and GMP audits
  • Experience with regulatory inspections and inspection readiness (EU experience is a plus)
  • Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs)
  • Experience reviewing and auditing study‐related documentation (e.g. nonclinical and clinical study
  • reports, Investigator’s Brochures, technical documents)
  • Strong team player with demonstrated track record of success in a cross‐functional team and fast moving environment
  • Excellent organizational, computing and oral/written communication skills
  • Ability to influence and negotiate effective solutions
  • Strong critical thinking and decision-making skills

Benefits

  • We offer a dynamic start-up environment and a collaborative, passionate team
  • Excellent benefits, including competitive employer contributions
  • Stock options
  • Paid vacation, sick time and holidays
  • Shuttle service to/from Caltrain, BART and the South San Francisco Ferry
  • State-of-the-art research facility and onsite gym (see the amenities available at The Cove: http://leasing.covessf.com/toc.cfm)

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.