Career | <?phpecho $jobTitle;?> | <?phpecho $companyName;?>

Senior Director, Quality Assurance

Surrozen

South San Francisco, CA, US
  • Job Type: Full-Time
  • Function: Life Sciences QA/QC
  • Industry: Biotechnology
  • Post Date: 09/20/2022
  • Website: surrozen.com
  • Company Address: 171 Oyster Point Blvd, South San Francisco, CA, 94080

About Surrozen

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.

Job Description

Reporting to the Chief Medical Officer, the Senior Director, Quality Assurance will act as the QA leader in the Surrozen organization and is responsible for setting QA strategy and building the QA department at Surrozen. In addition, the Senior Director will be responsible for all aspects of development and management of the overall quality systems including developing and implementing clinical and quality compliance plans, 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 is an exciting, new role for a highly qualified and motivated individual. This role will partner with Development Operations for all the GCP and GLP systems and activities, and with Technical Operations (CMC), legal and IT 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. This role is located in South San Francisco and we are open to candidates working remotely.

Requirements

  • Build quality organization and manage department budget
  • Establish phase appropriate GMP and GCP quality systems
  • Formulate GCP, GLP and GMP compliance strategy and provide advice for all programs within Surrozen
  • In collaboration with the CMC, Research and Development Organization, author phase appropriate QMS SOPs, Quality Manual, policies and work instructions.
  • Lead contract service provider qualification activities, audits and manage expert consultants as needed
  • Support functional departments to provide QA oversight for outsourced GLP, GCP and GMP operational activities
  • Review and approve Quality Agreements with CDMO/CMOs in collaboration with CMC
  • Develop, perform and manage audit programs with appropriate risk assessment and mitigations for both internal and external audits, including clinical study audit plans, audit report writing and CAPA plan evaluation
  • Promote quality culture and mindset by developing, implementing and improving a GXP training program
  • Provide management with updates of quality trends and potential risks
  • Prepare internal QA reports, and provide input for external partners reports and/or regulatory

filings

  • Accountable for the QA review of documentation submitted to regulatory agencies
  • Stay abreast of industry developments – forthcoming regulations, guidance, best practices, etc., and training and mentoring staff on global GXP regulations and guidance

 

Qualifications

 

  • 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 GXP regulations, guidelines and best practices
  • Experience in building a quality department and in establishing a GCP, GLP and GMP compliance strategy and environment
  • Experience in managing external vendors supporting outsourced quality related functions
  • Experience in early phase of biologics’ drug development.
  • Experience in planning and conducting GCP, GLP and GMP audits
  • Experience with global regulatory inspections and inspection readiness ()
  • Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs)
  • Experience reviewing and auditing GMP and Clinical and non-Clinical study‐related documentation (e.g. GMP batch release documentation, nonclinical and clinical study reports, Investigator’s Brochures, technical documents)
  • Strong solution-oriented team player with demonstrated track record of success in a cross‐functional team and a fast-moving environment
  • Excellent interpersonal, organizational, computing and oral/written communication skills

 

Benefits

We are an Equal Opportunity Employer offering a competitive salary and benefits

We use cookies to customize your user experience. Click “Agree” if you agree with our Policy.