Associate Director, Quality Assurance Vendor Management - Remote

Overview

Disc Medicine is hiring a new Associate Director, Quality Assurance Vendor Management due to the fast growth of the company’s portfolio. The successful candidate will serve as the primary manager of the vendor/Contract Service Provider qualification and audit program in all areas of GxP (GMP, GCP, GVP, GLP).

In Short

• Manage the GxP External Audit Program.
• Responsible for Internal Audit and coordination of External Audit processes.
• Develop and manage Inspection Readiness Program.
• Foster a positive workplace culture prioritizing collaboration.
• Collaborate with cross-functional teams for internal audits.
• Ensure compliance with internal policies and regulations.
• Monitor and report on audit program metrics.
• Support inspections at Contract Service Providers.
• Manage contracts for consultant auditors.
• Compile and monitor Contract Service Provider KPIs.

Requirements

• Bachelor’s degree with 10 years in a GxP Quality Assurance related field.
• At least 2 years conducting internal and external audits.
• Working knowledge of electronic Quality Management Systems (e.g., Veeva).
• Audit Certification is highly preferred.
• Knowledge of domestic and international GMP regulations.
• Outstanding communication skills.
• Able to manage multiple projects in a fast-paced environment.
• Strong cross-functional communication and organization skills.
• Requires a high degree of independence.
• Familiar with a variety of the field's concepts and practices.

Benefits

• Comprehensive benefits package.
• Competitive compensation.
• Flexible work environment.
• Opportunities for professional development.
• Inclusive company culture.