Director, Quality Operations - GxP & Compliance

Zevra Therapeutics; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Zevra Therapeutics in Boston is seeking a Director of Quality Operations to oversee the Quality Management System (QMS) across development and commercial activities, ensuring adherence to Zevra standards and regulatory requirements. The role demands building scalable, trusted cross-functional relationships to support programs from preclinical through commercialization.

The incumbent will manage audits, CAPA, serialization, vendor management, and quality reviews, while driving continuous

Qualifications

• 10+ years in pharmaceutical/biotech with pre-clinical to commercial exposure.
• 7+ years in Quality leadership with vendor oversight.
• 7+ years’ experience in GCP-, GLP- and GDP compliant systems.
• Bachelor's or Advanced degree in science or related field.
• Understanding of worldwide GxP requirements and regulatory inspections.

Responsibilities

• Review and approve IMP and commercial manufacturing documentation.
• Maintain compliant serialization system for commercial distribution.
• Lead investigations and CAPA for quality events and vendor ops.
• Support periodic Quality Management Reviews and annual product reviews.
• Coordinate internal and external audits and regulatory inspections.
• Assist in SOP creation and training aligned with QMS.

Skills

Quality leadership

GxP compliance

Vendor management

Regulatory inspections

Cross-functional leadership

Risk assessment

Serialization systems

Education

Bachelor's degree

Advanced degree in science

Job description

Zevra Therapeutics in Boston is seeking a Director of Quality Operations to oversee the Quality Management System (QMS) across development and commercial activities, ensuring adherence to Zevra standards and regulatory requirements. The role demands building scalable, trusted cross-functional relationships to support programs from preclinical through commercialization.

The incumbent will manage audits, CAPA, serialization, vendor management, and quality reviews, while driving continuous