ERT

  • Manager, GCP (Good Clinical Practice) Compliance

    Job Location US-PA-Philadelphia
    Shift
    Mon-Fri, 9-5
    Type
    Regular Full-Time
  • Overview

    ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.


    Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly — and with confidence.

     

     

    We are looking for a Manager, GCP Compliance. In this role you will develop the strategy for, and directs the overall management/support for inspections to ensure that all phases of Regulatory Health Authority inspections (i.e. inspection preparation activities, notification, inspection liaison activities during the inspection, development and approval of the inspection response (Inspection Response Document), and implementation of Corrective Action and Preventive Actions (CAPA) Plan) are handled consistently, professionally and proactively and result in outcomes that demonstrate the Company’s commitment to regulatory responsiveness and compliance.

    Responsibilities

    Essential Duties and Responsibilities:

     

    • Lead the preparation, notification, conduct and follow-up of any Regulatory Health Authority inspections of ERT; collaborates with and guides employees within ERT in order to ensure that Regulatory Health Authority inspections are adequately managed, supported and facilitated. 

     

    • Serves as the primary point of contact for clients subject their own Regulatory Health Authority inspection (e.g. Site/Sponsor inspections). Coordinates the internal ERT personnel and documentation necessary to support the Site/Sponsor inspection.

     

    • Develops an inspection preparation plan for programs/trials and provides oversight and tracking of all activities.
    • Ensures that, as a result of inspection preparation, storyboards are being developed for key processes and activities.
    • Ensures that a cross-functional team (e.g. Quality, IT, R&D, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.
    • Maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and CAPAs, worldwide.
    • Acts as the subject matter expert and primary point of contact for relevant functional areas on Inspection Support/Inquiries to provide real-time, proactive advice and guidance.
    • Escalates potential significant inspection findings/compliance risks/impact to Senior Management.
    • Tracks all submissions to Health Authorities to ensure that inspection preparation plans are implemented in a timely manner and informs ERT Senior Management.
    • Responsible for the identification and impact analysis of changes to GCP regulations globally.
    • Responsible for ongoing identification of opportunities to further develop and improve GCP Inspection Management strategy, processes, tools and templates.
    • Ensures that all actions and commitments related to inspections are implemented in a timely manner. Tracks all inspection CAPA commitments and checks evidence of completion.
    • Provides input into Senior Management Quality regarding Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments.

    Other Duties and Responsibilities:

    • Reviews inspection activities and results for developing lessons learned.
    • Assesses and provides input to strengthen company programs/strategies with an aim to increase ERT Inspection Readiness.
    • Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed.


    The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required.  This job description and any attachments do not constitute or represent a contract.

    Qualifications

     

    Qualifications and Skills Needed:

    1. A Bachelors' Degree or equivalent in relevant health care area.
    2. A minimum of twelve (12) years of relevant experience in clinical research.
    3. A minimum of three (3) years of direct experience with managing worldwide Regulatory Health Authority inspections (e.g. FDA, EMA, MHRA).
    4. Profound knowledge and understanding of clinical development programs and clinical trial processes as well as quality management systems and quality control tools is required.
    5. Comprehensive knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
    6. Experience with delivering effective CAPA management solutions:
    7. Experience conducting sponsor/site audits
    8. Direct field monitoring experience, with a demonstrated record of accomplishments.
    9. Excellent organizational, interpersonal, verbal, and written communication skills
    10. Ability to work effectively as part of an integrated project team, while also taking ownership of assigned tasks to successfully achieve explicit delivery dates and milestones

     

    ERT is an equal opportunity employer and all qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

     

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