• Director, Quality Systems
• Job Type: Permanent
• Location: Waltham, MA. Site based
• Salary: Up to $230K + Bonus + Benefits

The company is a cutting-edge clinical-stage biotechnology company mainly dedicated to the Nephrology space. They have a dynamic pipeline of groundbreaking therapies.

As the Director, Quality & Compliance, you will take a leading role in advancing and overseeing the Quality Management System to align with relevant global regulatory standards and company business goals. This position offers significant visibility within the organization.

Responsibilities

• Oversee companywide GxP training programs, aligning training requirements with job functions.
• Lead the development and maintenance of the audit and inspection readiness programs.
• Contribute to the continuous improvement of the inspection readiness program and new initiatives.
• Develop, review, and monitor quality agreements and contracts.
• Manage GxP Training, Supplier Management, and documentation systems.
• Support the Quality Management Review process by analyzing and reporting on Quality System and supplier performance metrics.
• Oversee the supplier qualification program, including audit planning and execution.
• Develop and enhance scalable quality processes to meet organizational growth.
• Cultivate a quality mindset across the company through risk-based decision-making.
• Assist in presenting management reviews of quality compliance and operational KPIs to address unfavorable trends promptly.

Qualifications

• Minimum 15+ years in Biopharmaceutical Quality or Compliance roles
• BA/BS Degree in a sciences discipline
• In-depth knowledge of GxP, Quality Systems, and Compliance for safety, data integrity, and product quality
• Recent experience managing and influencing stakeholders on GxP topics
• Experience in leading inspection readiness initiatives
• Experience with Veeva and ComplianceWire

Please reach out to or call +1 646 492-5308 for further details.