Senior Quality Systems & Compliance Leader

MacroGenics; Rockville (MD); On-site; USD 138,000 - 210,000; Full time

Benefits offered by this job

Discretionary bonus

Discretionary equity incentives

Health/dental/vision benefits

401(k) with employer match

Employee Stock Purchase Plan (ESPP)

Paid time off & parental leave

Disability benefits

Job summary

MacroGenics in Rockville, MD seeks a Senior Manager, Quality Systems & Compliance to lead the Quality Management System ensuring GMP, GCP and GLP compliance across QA, Technical Operations and Clinical Development.

Responsibilities include electronic QMS deployment, SOP authoring, training management, and regulatory inspection readiness, with cross-functional collaboration across IT and external partners. 7+ years in GxP and biopharma are required.

Qualifications

• Bachelor's degree in a science-related field with GxP experience.
• Minimum 7 years in a GxP environment, with biopharma exposure.
• Experience implementing and administering an eQMS.

Responsibilities

• Lead electronic QMS deployment, administration and improvements.
• Develop site quality systems for GMP, GCP and GLP; drive training.
• Author SOPs, work instructions and controlled documents.
• Own document management for electronic and paper systems.
• Oversee company-wide training and ensure role-specific GxP training.
• Drive inspection readiness and participate in regulatory audits.
• Support deviations, CAPA, OOS/OOT, change control and SCAR processes.

Skills

Quality Systems

GxP Regulations

USFDA cGMP

Cross-functional communication

Regulatory inspections

Biopharma

Training & document control

Deviations & CAPA

Education

Bachelor’s degree in science

Tools

eQMS

Job description

MacroGenics in Rockville, MD seeks a Senior Manager, Quality Systems & Compliance to lead the Quality Management System ensuring GMP, GCP and GLP compliance across QA, Technical Operations and Clinical Development.

Responsibilities include electronic QMS deployment, SOP authoring, training management, and regulatory inspection readiness, with cross-functional collaboration across IT and external partners. 7+ years in GxP and biopharma are required.