Quality Systems & Compliance Lead (GxP, GMP)

MacroGenics, Inc.

Rockville (MD)

On-site

USD 138,000 - 210,000

Full time

14 days+

Application generator

Turn this role into an interview — a resume and cover letter built around what this employer wants.

Get past ATS filters

Job summary

MacroGenics, Inc. is seeking a Senior Manager, Quality Systems to lead the Quality Management System (QMS) and ensure GMP, GCP, and GLP compliance across clinical and outsourced operations.

The role requires cross-functional partnership with Technical Operations, Quality, and Clinical Development to drive continuous improvement and readiness for inspections. The candidate will own document management, training programs, and regulatory support activities while shaping phase-appropriate quality

Qualifications

Bachelor's degree in a science field; minimum of 7 years in a GxP environment.
Minimum 5 years experience with biologics regulated under 21 CFR Part 600.
Prior experience implementing and administering an eQMS for a biopharmaceutical company.

Responsibilities

Oversee electronic QMS deployment, administration, and continuous improvement; coordinate with IT and external support to mature the quality processes.
Develop site quality systems aligned with phase-appropriate regulatory standards and company strategy.
Author and review QMS docs (SOPs, work instructions) and manage document control systems.

Skills

Quality systems experience

USFDA cGMP knowledge

Cross-functional communication

GxP compliance

Training program management

Quality auditing

Biologics knowledge

Education

Bachelor's degree in science

Tools

eQMS software

Quality documentation tools

Job description

MacroGenics, Inc. is seeking a Senior Manager, Quality Systems to lead the Quality Management System (QMS) and ensure GMP, GCP, and GLP compliance across clinical and outsourced operations.

Get your free, confidential resume review.

or drag and drop your file here.