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QA Clinical Director

QA Clinical Director

  • Location

    Lakehurst

  • Sector:

    Quality & Validation

  • Job type:

    Permanent

  • Salary:

    £84.4k per year

  • Contact:

    Callum Sparkes

  • Contact email:

    Callum.Sparkes@jcwresourcing.com

  • Contact phone:

    02035899300

  • Job ref:

    LM45641

  • Published:

    10 months ago

  • Expiry date:

    2019-08-02

  • Consultant:

    #

Overview

A West-Coast based late-stage pharmaceutical company that is developing drug treatments for central nervous system (CNS) disorders is looking for an experienced Quality individual with a clinical operations profile to join their exciting team in order to bridge the Quality and Clinical Operations functions in a Director level role.

If you're based in Pennsylvania, New Jersey, New York, or Massachusetts, (as they are looking to open an East-Coast office in one of these locations) and are looking for that next step in your career in a role that will give you autonomy to mould it into how you best see fit, then apply now!

Essential Duties and Responsibilities Include the Following.

  • Meet the ongoing needs of the quality assurance department by maintaining CQA compliance for ongoing and planned clinical trials.
  • Work with clinical operations and regulatory affairs to review IND and NDA submission documents.
  • Lead investigations and write CAPAs on GCP issues as they arise.
  • Responsible for ensuring submission data and documentation meets GCP guidelines.
  • Perform and/or support audits of clinical sites, CROs and other clinical vendors.
  • Ensure proper maintenance of the Quality systems.
  • Directly interface with Clinical Operations to provide support for vendor, site, and internal GCP audits.
  • Assist with writing and editing documents needed for the clinical quality management system.
  • Update and maintain CQA SOPs that support the quality systems.
  • Manage and update electronic libraries.
  • Assist in authoring clinical operation SOPs and processes as needed.
  • Facilitate meetings with CRO's and other clinical entities as appropriate.
  • Ensure Trial Master Files are maintained within standards.
  • Other duties as assumed or assigned.
  • Develop and support established records management procedures.
  • Provide input and change management for quality improvements affecting CQA systems.

Education, Experience and/or Skills Required

  • 10 cumulative years of related quality or clinical experience within pharmaceutical companies or Contract Research Organizations (CROs).
  • Education and experience in an FDA-regulated environment.
  • Bachelor's degree
  • Ability to plan and organize work in an efficient manner and work well under time constraints.
  • Demonstrates effectiveness in maintaining CQA control systems for compliance with FDA regulations.
  • Must have experience using MS Office
  • Broad knowledge of clinical processes and procedures, electronic documentation systems, and Good Clinical Practices 21CFR Parts 50, 56, and 312.
  • Demonstrates initiative and proactively provides collaborative support to the clinical teams.
  • Experience in MasterControl or a similar ECM system is a plus.
  • Willing to travel 20-30%.