Manager, GxP Audits & Inspections (REMOTE)

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

Reporting to the Associate Director, GxP Audits and Inspection Management, this role will support oversight of the Seres GxP Audit /Inspection program as well as management of external auditors. This includes internal, external, vendor, 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

• Bachelor's degree in life sciences, orengineering with minimum 10 years of experience in the pharmaceutical or biotechnology industry
• Minimum 8 years of 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 and Computer System Validation.
• 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

Candidates should be aware that Seres Therapeutics currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19. Newly hired employees must be vaccinated prior to their employment start date.

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.

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