Associate Director, Supplier Qualification

Xeris Pharmaceuticals•Chicago, IL

1d•Hybrid

About The Position

The Associate Director, Supplier Qualification, is responsible for leading the global GxP audit program and the end-to-end supplier qualification lifecycle to ensure compliance with applicable regulatory requirements and internal quality standards. This role provides strategic oversight of external and internal audits, manages supplier risk, drives operational excellence, and partners cross functionally to support a mature, risk-based Quality Management System (QMS). The individual serves as a subject matter expert (SME) in GxP auditing practices, vendor oversight, and quality risk management, ensuring the organization maintains inspection readiness and a robust, compliant supply network.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or related field.
8+ years of experience in GxP Quality Assurance roles within pharmaceutical, biotech, or medical device industries.
Strong experience in GCP and/or GMP auditing (lead auditor certification preferred).
Demonstrated knowledge of FDA, EMA, and ICH regulations and guidance.
Experience managing supplier qualification programs and external vendor oversight.
Excellent writing, communication, and negotiation skills.
Ability to influence cross-functional stakeholders and work effectively in a matrixed environment.

Nice To Haves

Advanced degree (MS, MBA, or related).
Experience with virtual/outsourced manufacturing models.
Familiarity with risk management methodologies (ICH Q9), quality metrics, and data-driven program management.
Experience supporting regulatory inspection and aseptic processing.
Experience working in a cGMP production environment, preferably with injectables and combination products.
Prior leadership or team management experience.

Responsibilities

Lead the supplier qualification and requalification program, including initial assessments, risk evaluations, and ongoing lifecycle monitoring.
Partner with Procurement, Manufacturing, Technical Operations, and Quality leaders to ensure suppliers meet performance and compliance expectations.
Lead external audits of Xeris suppliers (Contract Manufacturers, APIs, Excipients, Primary and Secondary Packaging, Contract Laboratories, and all Services) against audit standards (21 CFR 210, 21 CFR 211, relevant USP, Combination Product and ISO standards).
Drive closure of corrective and preventive actions to ensure sufficient controls are in place by the supplier to meet Xeris specifications and quality requirements.
Lead and / or assist with the development of compliance and quality training as required.
Author, revise, and review SOPs, work instructions, and quality documents to ensure documentation defines the steps necessary to complete required audit tasks.
Author and maintain audit related documents and database records to ensure all data is current, complete, and accurate.
Maintain supplier quality agreements and ensure alignment with operational requirements and regulatory expectations.
Planning, scheduling, coordinating and performing supplier and internal audits to ensure compliance with applicable US FDA cGMP regulations and industry standards.
Author detailed Audit Reports to communicate audit findings to auditees and Xeris management.
Evaluating audit finding responses from suppliers for adequacy, including root cause determination, CAPA activities and tracking through to closure.
Managing and overseeing approved supplier list and qualification related records
Collecting, trending and reporting supplier quality metrics including preparing trending graphs and data for Quality Management Review presentations.
Support the Internal Audit program including developing audit plans, conducting internal audits, writing audit reports, evaluating audit finding responses and tracking through to closure.
Works in collaboration with contract manufacturing partners to obtain necessary Quality documents, complete compliance reviews and facilitate timely product release activities, as needed.
Supports management during external inspections.
Provides support to other areas in quality department, including but not limited to, quality and compliance review of manufacturing batch records, change control, standard operating procedures, product complaint, CAPA, and investigations.
Remains current in regulatory trends and requirements.