Radius Health, Inc.

  • Senior Director, GCP Quality Assurance

    Job Locations US-MA-Waltham
    Posted Date 2 weeks ago(8/8/2018 2:59 PM)
    Job ID
    2018-1779
    # of Openings
    1
    Category
    Quality - Dept
  • Overview

    The Senior Director, GCP Quality Assurance applies knowledge, expertise and global experience in the principles and applications of GCP, GLP and GVP Quality ICH guidelines to lead related vendor and internal audits, procedure development, identification and monitoring of deviations, investigations and CAPAs, and Inspection Readiness.

    Responsibilities

    • Proactively provide consultative GCP QA support to global clinical development activities to protect patient safety, maintain data integrity, and support operational efficiency
    • Work dynamically and proactively with Quality Assurance and Functional Area leads to facilitate development of GXP-compliant procedures to support conduct of clinical studies and prepare the company to successfully commercialize pharmaceutical products
    • Assist with the organization, planning, preparation, coordination, and documentation of regulatory inspections
    • Lead, and/or conduct, global Good Clinical Practice (GCP), Good Laboratory Practice (GLP) Audits of systems and processes related to pre-clinical and clinical drug development and operations
    • Lead, and/or conduct/support (in collaboration with GMP QA colleagues), global Good Pharmacovigilance Practice (GVP) Audits of systems and processes related clinical and post-market patient safety information collection, evaluation and reporting
    • Select and manages contractors who provide contract audit services
    • Lead quality investigations, including generation and follow-up of Corrective and Preventative Action (CAPA) plans
    • Lead GCP/GLP-related refinements and improvements to the Quality System of controlled procedures (Policies, SOPs, Work Instructions, etc.) and Quality IT Solutions, including the Quality EDMS and QMS applications
    • Provide GCP compliance oversight of internal systems and processes as well as those of CROs, Vendors, and Clinical Investigator Sites
    • Review and provide input to clinical documentation (e.g. protocols, study reports, IBs, ICFs, etc.)
    • Develop and measure quality metrics to drive consistent standards throughout the organization

    Qualifications

      • Bachelor’s degree required with 10+ years relevant experience in Pharmaceutical or Biotechnology and/or Medical Device Quality Assurance (in sponsor companies, CROs, or GCP consulting), with at least 5+ years global GCP specific experience.
      • Demonstrated ability to effectively communicate and influence the outcomes of the decision-making process, conveying an appropriate sense of urgency.
      • Analytically strong, with great attention to detail.
      • Practical knowledge and experience identifying key performance metrics for quality indicators, setting targets to maintain a state of control while identifying areas for improvement.
      • Extensive experience auditing clinical CRO’s, vendors, and clinical sites.

                

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed