• GLP/GCP QA Specialist III / Manager, GLP, GCP QA

    Job Locations US-MA-Bedford
    Posted Date 2 months ago(5/8/2019 11:00 PM)
    Job ID
    2019-1233
    # of Openings
    1
    Category
    Quality
  • Overview

    This position reports to the Director of Clinical Quality Assurance and will be responsible for all Quality Assurance GLP activities and provide a supporting role in GCP activities. The primary responsibilities will be to ensure quality and compliance of Ocular Therapeutix-sponsored nonclinical and clinical studies with respect to Standard Operating Procedures, applicable regulatory requirements (FDA/EU/ICH/country-specific and current industry standards and practices).

    Responsibilities

    •Develop and implement detailed audit plans and yearly GCP/GLP master audit schedules
    •Work with contract auditors on scheduling, preparation, conduct of audits; review audit reports, review/follow-up on responses, and file all audit-related documentation
    •Schedule, prepare for and conduct audits (investigator sites, vendors (GLP/GCP), internal process, Trial Master File and document audits (eg, Clinical Study Reports, Investigator Brochures, GLP reports and other submission reports) as needed, write audit reports and review/follow-up on responses
    •Assist in the development of GLP/GCP QA SOPs
    •Attend study team meetings and provide GLP/GCP guidance/advice
    •Ensure the timely and effective follow-up of all identified or assigned quality issues through a Corrective Action/Preventive Action (CAPA) system
    •Support gap analyses and updates to the Quality Management System from a risk-based perspective
    •Assist in the development/implementation of an Inspection Readiness program and assist during regulatory authority inspections
    •Assist with metric and trending of Key Quality Indicators

    Qualifications

    •Bachelor’s Degree in a scientific discipline or relevant education and applicable job experience
    •Minimum of 5 years in the Pharmaceutical industry in GLP QA
    •Solid understanding of GLP, GCP and ICH clinical requirements
    •Experience with both domestic and international clinical studies
    •Excellent writing, organizational and collaboration skills
    •Able to travel domestically and internationally approximately 25-30% of the time
    •Regulatory inspection experience is a plus

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