Manager, QA (GxP Audits and Inspections) (HYBRID)

Company: Seres Therapeutics, Inc.
Location: Cambridge
Posted on: March 15, 2023

Job Description:

Why Seres Therapeutics
Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease.OurSER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.
Seres Therapeutics is a member of the Flagship Pioneering family of companies.
Position Summary
This role will provide oversight of the GxP Audit and Inspections (GMP/GCP/GVP) as well as the management of external auditors. This includes internal, external, vendor, CMO, CRO and other assessments/audits as determined to support the business performed on behalf of Seres Therapeutics.
What You'll Do

• 
  
• Support development and implementation an annual GxP audit plan in coordination
  
• with functional areas including but not limited to Manufacturing, Donation Operations, R&D
  
• and Clinical.
  
• Select and oversee external auditors.
  
• Maintain training records, CVs, SOPs, etc. of external auditors
  
• Schedule audits with external auditors per audit plan.
  
• Oversee the development of audit plans and work with the business leads to assure they meet the needs within CMC, R&D and Clinical.
  
• Review audit reports to assure they are clear and cover the most important information to support successful development of CAPA's
  
• Prepare audit performance metrics to assure audit program is conducted per standards and SOPs
  
• Perform audit trending of audit findings to assist QA and organization in identifying potential risks and supporting continuous improvement
  
• Assure all audit plans, reports, CAPAs and certificates are appropriately archived
  
• Support supplier qualification activities including review of questionnaires and vendor approvals.
  
• Evaluate Audit and Inspection Program processes for continuous improvement opportunities.
  
• Support Seres GxP Quality System projects, programs and functional area initiatives as required
  
• Support ongoing inspection readiness activities, as needed
  
• Other activities to support the Quality System team, as directed
  
  What You'll Bring
  
  • 
    
  • Support development and implementation an annual GxP audit plan in coordination with functional areas including but not limited to Manufacturing, Donation Operations, R&D and Clinical.
    
  • Select and oversee external auditors.
    
  • Maintain training records, CVs, SOPs, etc. of external auditors
    
  • Schedule audits with external auditors per audit plan.
    
  • Oversee the development of audit plans and work with the business leads to assure they meet the needs within CMC, R&D and Clinical.
    
  • Review audit reports to assure they are clear and cover the most important information to support successful development of CAPA's
    
  • Prepare audit performance metrics to assure audit program is conducted per standards and SOPs
    
  • Perform audit trending of audit findings to assist QA and organization in identifying potential risks and supporting continuous improvement
    
  • Assure all audit plans, reports, CAPAs and certificates are appropriately archived
    
  • Support supplier qualification activities including review of questionnaires and vendor approvals.
    
  • Evaluate Audit and Inspection Program processes for continuous improvement opportunities.
    
  • Support Seres GxP Quality System projects, programs and functional area initiatives as required
    
  • Support ongoing inspection readiness activities, as needed
    
  • Other activities to support the Quality System team, as directed
    
    Seres is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.
    #LI-KC1

Keywords: Seres Therapeutics, Inc., Cambridge , Manager, QA (GxP Audits and Inspections) (HYBRID), Executive , Cambridge, Massachusetts