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Sr. Manager, GxP Audit/Inspection Lead - Contractor

Department: QA/QC
Location: Cambridge, MA

*Contract opportunities are manged directly by Stratacuity.

Sr. Manager, GxP Audit/Inspection Lead - Contractor

Seres Therapeutics is well-positioned to become the first company to bring an approved microbiome drug to patients through our proprietary discovery and design platform. We identify key alterations in the microbiome that are associated with specific diseases, and are designing live bacterial ecologies to act as therapeutics.

What’s Your Mission?

The Sr. Manager, GxP Audit/Inspection Lead will work closely will be responsible for managing the vendor qualification program and perform internal and external audits. The incumbent will be expected to work with project teams to select and qualify vendors to support clinical development programs. In addition, the individual will work with project teams to ensure clinical studies and supporting activities are conducted in compliance with GxP. 

What You’ll Do

  • Design, develop and implement risk based audit standards and SOPs utilizing external auditors to perform audits and vendor assessments. 

  • Develops and implements a GxP audit plan in collaboration with Heads Quality Assurance supporting CMC, Donation Operations, R&D and Clinical.

  • Select and oversee external auditors.  Perform co-audits/audits as needed.

  • 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 internal managers to assure they meet the needs within CMC, R&D and Clinical.

  • Assure smooth execution of the audit plan by scheduling kick-off/close out meetings as needed with internal and external stakeholders.

  • Review audit reports to assure they are clear and cover the most important information to support successful development of CAPA’s

  • Track closure of Critical and Major Audit Findings.

  • 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 appropriate archived in QA and Clinical files.

  • Develop processes and assisting in the planning, executions and close-out of external audits/inspections.

 

What You’ll Bring

  • 8-10 years of experience in the pharmaceutical or biotechnology industry with GxP QA Audit and/or Regulatory Inspection experience.

  • Advanced knowledge and demonstrated experience in the applicable GXP regulations, FDA Good Manufacturing and Clinical Practices, ICH Guidelines, Global Drug Development Regulations and Guidance’s, Computer System Validation, and Project Management.

  • Advanced experience in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to subject protection and data integrity.

  • Demonstrated ability to effectively organize and execute tasks. Strong verbal and written communication (including presentation) and customer management skills.

  • ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional preferred.

 

Who We Are

Seres Therapeutics is a clinical stage biotherapeutic company focused on discovering and developing Ecobiotic™ therapeutic products, novel drugs to treat important diseases by targeting the underlying biology of the human microbiome. Founded by Flagship VentureLabs, Seres is pioneering the first therapeutics that catalyze a shift to health by augmenting the biology of the microbiome. Current candidates span infectious, metabolic, and inflammatory diseases. For more information, please visit http://serestherapeutics.com/

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