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    Associate Director, QP - Dublin, Ireland - Sarepta Therapeutics

    Sarepta Therapeutics
    Sarepta Therapeutics Dublin, Ireland

    1 week ago

    Default job background
    Full time
    Description
    The QP is the person responsible for ensuring batch production compliance with EU regulations and handing off to CMO or partner QP for final release of batches of Gene Therapy and RNA products. The QP will work with Sarepta QA operations and CMOs to assess the manufacturing compliance with EEA regulations in order to certify product for distribution. The QP will maintain a thorough and up to date understanding of international regulatory guidance.

    Primary Responsibilities Include:

  • Certifying Medicinal Products for use in the EU and outside the EU (where relevant).
  • Ensuring continued compliance, operationally, to the company's licenses for Marketed Products, Investigational Medicinal Products and unlicensed medicines.
  • Reviewing Batch Manufacturing Documents to ensure compliance with EU GMP and the Product Specification File/marketing authorization (or other where relevant) as defined in 2001/83/EC, 2001/82/EC, 2011/62/EU and Eudralex Volume 4, Annex 16, EU Regulation No. 536/2014 and Commission Delegated Regulation No. 2017/1569 supplementing.
  • Undertaking audits in the EU and third countries to ensure that Sponsor or MA Holder manufacturing sites are operating in general compliance with EU GMP.
  • Providing advice and guidance to the company's staff and customers regarding QP requirements within the EU.
  • Keeping up to date with the requirements of the Medicines Authorities across the EU and rest of world (where relevant).
  • Reviewing the company's Project Specification Files (PSFs, commercial project files etc.) to ensure compliance with the current regulatory requirements and company procedures.
  • Aid with regulatory inspections and client audits.
  • Supporting the Quality Assurance Department in managing the QMS and assisting in quality investigations.
  • Undertaking departmental tasks and projects outside the job holder's area of responsibility, in line with departmental and senior management team objectives.

    • Desired Education and Skills:

  • Eligible to act as a Qualified Person (QP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with EU directive 2001/83/EC, EU Clinical Trial Regulation 536/2014 and the requirements of Annex 16.
  • Bachelor's degree in the Life Sciences with 5-10 years in pharmaceutical or biotech drug. Experience working as a QP in the certification of sterile medicinal products, biopharmaceuticals or ATMPs would be an advantage.
  • GMP audit experience, preferably qualified as Lead Auditor.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Exceptional organizational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Collaborative team player with a positive attitude and the ability to think and act quickly to identify creative solutions to complex problems.
  • Strong judgment and decision-making skills.
  • Global experience is preferred.
  • Domestic and International travel required.
    • #LI-Hybrid
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