Senior Manager/Associate Director, GxP Quality Assurance

THE ROLE

We are seeking a dynamic, highly motivated Senior Manager/Associate Director, GxP Quality Assurance to join our team, reporting to the Head of Quality in South San Francisco, CA. This role functions as both a strategic and hands-on quality professional, responsible for managing and administering GxP Quality Assurance and Quality Management System (QMS) activities. As the QMS owner, the incumbent ensures compliance in a phase-appropriate manner by establishing and continuously improving quality system procedures and policies across GxP functions. The position also drives organizational process excellence, champions continuous improvement initiatives, and collaborates with leaders across the organization to support Septerna’s long-term success.

Strong initiative and follow-through are essential for achieving target quality objectives. Additional responsibilities include analyzing key compliance indicators, tracking performance metrics, and maintaining required GxP quality records. The role requires the ability to work independently in a fast-paced environment while upholding confidentiality and high ethical standards.

Responsibilities 

• Manage and execute GxP Quality Assurance and QMS activities, ensuring compliance with policies and procedures.
• Administer and maintain QMS records, including deviations, CAPAs, complaints, and change controls, ensuring timely investigation, documentation, and closure.
• Implement and maintain the electronic Quality Management System, troubleshoot issues, and communicate system updates across GxP functions.
• Drive GxP quality system initiatives, focusing on effective implementation, adherence to regulatory requirements, and seamless communication across organization.
• Independently execute strategies in support of GxP quality system implementation.
• Facilitate vendor management activities by coordinating, scheduling, and prioritizing GxP audits, supporting the successful execution of the end-to-end audit lifecycle, including planning, tracking, follow-up, and closure.
• Manage and administer the document control and training program, ensuring documents are properly processed, approved, and archived.
• Drive Quality Management Review activities, ensuring accurate tracking, monitoring, analysis, and reporting of compliance KPIs/metrics. Develop and maintain QMR presentations with precise data.
• Coordinate Quality Management Notifications, including triage, tracking, and follow-up through closure to ensure timely resolution of quality-related issues.
• Stay current with evolving regulations, quality trends, and industry best practices through continuous learning, research, and professional engagement.
• Collaborate with cross-functional teams to ensure timely closure of GxP quality records, including Deviations, CAPAs, Change Controls, and Complaints.
• Manage product complaint handling, analyze complaint data, and generate quarterly trend reports.
• Assist with drafting and revising Standard Operating Procedures to maintain compliance with quality objectives.
• Undertake additional projects and responsibilities as assigned by the Head of Quality.

Qualifications

• B.S. or B.A. in a relevant scientific discipline (advanced degree a plus).
• 10–12 years of Quality Assurance experience in the pharmaceutical or biotechnology industry within a GxP environment, including 5–8 years in a QMS-focused role spanning clinical phases through commercialization.
• Strong knowledge of GxP regulations (GMP, GLP, GCP) and quality systems.
• Experience with QMS and eQMS implementation, including continuous improvement and KPI tracking.
• Hands-on experience with audits, regulatory inspections, deviations, CAPAs, and change controls.
• Excellent problem-solving, critical-thinking, and communication skills.
• Ability to manage multiple projects in a fast-paced, high-growth environment.
• Proficiency in Microsoft Office and electronic documentation systems.
• Willingness and ability to travel as needed.

The anticipated salary range for candidates who will work in South San Francisco, CA is $175,000 - $200,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.

Salary : $175,000 - $200,000