Overview
Director, Quality systems Jobs in Waltham, Massachusetts, USA at Skills Alliance
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 company wide 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 Compliance Wire
Please reach out to David.fearnley@ or call  for further details.
Title: Director, Quality systems
Company: Skills Alliance
Location: Waltham, Massachusetts, USA
Category: Quality Assurance – QA/QC, Management
