• Supplier Quality Manager

    Job Locations US-MA-Bedford
    Posted Date 3 months ago(3 months ago)
    Job ID
    2018-1072
    # of Openings
    1
    Category
    Quality
  • Overview

    Reporting to the Director, Compliance QA, the Supplier Quality Manager will lead Supplier Quality activities to ensure uninterrupted supply of materials and services to Ocular Therapeutix.  He/She will support the development, execution and maintenance of the Supplier Quality Management system, including implementing processes to assess the quality and risk of the Suppliers. As an experienced auditor and Supplier Management professional, the Supplier Quality Manager will lead in the completion of activities to ensure appropriate approval and ongoing control / oversight of suppliers, including Supplier Auditing and establishment of Quality Agreements.

    Responsibilities

    •Support the establishment of a risk based program for the continual and appropriate oversight of all GMP suppliers
    •Lead in the authoring and implementation of Quality Agreements
    •Perform Supplier Quality assessments / audits of Suppliers to plan and follow up on agreed upon corrective actions
    •Develop systems for the reporting of Supplier Quality performance, including Risk Assessment ranking and defined KPIs
    •Execute supplier approval steps for materials and services, ensuring robust supply chain integrity
    •Monitoring and reporting on supplier quality metrics, quality agreements with critical suppliers, and quality of supplier records to drive supplier quality management
    •Support with Inspection Execution as required
    •Support and/or lead in the conduct of internal audits
    •Support with other Compliance activities as required, including:
    oProvide coverage for Documentation and Training QS Manager, as required
    •Perform other duties as assigned

    Qualifications

    •Bachelor’s degree in Life Sciences
    •At least 8 years’ experience in the pharmaceutical or biopharmaceutical industry. At least 4 years Supplier Quality Management and auditing experience
    •Excellent knowledge of US cGMPs
    •Knowledge or experience of auditing to GCP requirements preferred
    •Certified Quality Auditor (ASQ or equivalent) preferred
    •Ability to travel ~20%
    •Strong interpersonal, negotiation and communication skills

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