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Sr. Manager/AD GxP Quality Management/Compliance

Department: QA/QC
Location: Cambridge, MA

Sr. Manager/AD GxP Quality Management/Compliance

As part of the QA shared services group designs, develops, & implements Seres GxP Quality Management Program to assure quality metrics, analytics and quality risk management principles are integrated within CMC and Clinical Development practices and processes.

Key Responsibilities:

  • Create key quality metrics for tracking and trending data related to GCP activities, report metrics, and significant quality incidents to QA management.
  • Support CMC/Clinical/QA team with relevant compliance and data outputs in support of organizational and departmental operational and compliance metrics, including implementation of key compliance, quality, and performance indicators (KCIs/KQIs/KPIs) across functions.
  • Support organization in the implementation and training of processes around quality risk management and knowledge management, and is capable to design risk-based mechanisms of “data” oversight.
  • Support project teams for internal and external Investigations, identifying root cause of Quality and Compliance issues, and planning appropriate Corrective and Preventative Actions (CAPAs).
  • Work with QA Business Partners to develop tools to track, trend, and metrics to be used to assure ongoing review/closure and for use during Quality Management Review meetings within
  • CMC/Donation Operations and Clinical Development.
  • Organize, lead, and document processes for Quality Management Review with QA Leads within Clinical Development, CMC and Donation Operations
  • Manage and Oversee Change Control Process
  • Oversees the Quality Agreement program working with the appreciate groups ensuring agreements are in place.
  • Assist GxP Audit Lead, as needed, in external audits and/or regulatory inspections including tracking of any commitments

Qualifications:

  • Bachelor’s degree in the life sciences
  • 8 to 10 years of experience in the biotech/or pharmaceutical industries working in a Quality
  • Management/Quality Compliance role in R&D and commercial organizations.
  • Demonstrated experience in developing analytics and quality metrics
  • Strong analytical skills in assessing business processes, systems, and information flows, as well as compiling and assessing data/trends
  • Proficiency with advanced features of Microsoft Excel, pivot tables, charting, etc.
  • Demonstrate strong organizational and interpersonal skills, building relationships with effective communication, influencing, conflict resolution, critical thinking and problem solving with a keen attention to detail.
  • Advanced knowledge and demonstrated experience in the applicable GXP regulations, FDA Good Manufacturing and Clinical Practices, ICH Guidelines, guidelines for quality metrics and quality risk management.

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