Director, Quality systems Job at Skills Alliance, Waltham, MA

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  • Skills Alliance
  • Waltham, MA

Job Description

  • 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 David.fearnley@skillsalliance.com or call +1 646 492-5308 for further details.

Job Tags

Permanent employment,

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