Senior Director, External QC Strategy & Compliance

Xeris Pharmaceuticals Inc; Georgia; On-site; USD 225,000 - 337,000; Full time

Benefits offered by this job

Paid time off

Health insurance

401(k) retirement plan

Equity or long-term incentive awards

Annual bonus

Comprehensive benefits

Job summary

Xeris Pharmaceuticals Inc. seeks a Senior Director of Quality Control to lead outsourced GxP testing operations supporting clinical and commercial products.

The role builds and maintains robust QC systems, aligning with QA, Regulatory, and external partners to ensure product safety, quality, and compliance. The position bases in Chicago, requires in-office presence four days a week, and oversees strategic frameworks for external labs, data integrity, and regulatory submissions across INDs,

Qualifications

• Bachelor’s degree in biotechnology, chemistry, or related field with 18+ years of experience and at least 12 years in a QA/QC environment in the pharmaceutical industry.
• Demonstrated expertise in GxP environments and quality systems supporting investigations, CAPAs, and regulatory readiness.

Responsibilities

• Lead and mentor the external QC network, ensuring compliant workflows for data entry and archiving.
• Oversee vendor management, contract lab evaluation, performance monitoring, and PO/invoicing processes.
• Provide strategic oversight of clinical and commercial release and stability testing programs and associated data reviews.
• Govern investigations for out-of-specification (OOS) and out-of-trend (OOT) events and CAPA ownership.
• Manage reference standards and reagents lifecycle across external testing providers.
• Coordinate raw material testing strategies including APIs, excipients, and delivery devices.
• Oversee analytical method validations/transfers and establish product specification management.

Job description

Xeris Pharmaceuticals Inc. seeks a Senior Director of Quality Control to lead outsourced GxP testing operations supporting clinical and commercial products.

The role builds and maintains robust QC systems, aligning with QA, Regulatory, and external partners to ensure product safety, quality, and compliance. The position bases in Chicago, requires in-office presence four days a week, and oversees strategic frameworks for external labs, data integrity, and regulatory submissions across INDs,