GMP Compliance Manager

5 days ago


Dublin, Dublin City, Ireland Glaxosmithkline Full time
Quality Assurance Lead

We are seeking an experienced Quality Assurance Lead to join our Pharma R&D team. In this role, you will be responsible for ensuring the quality and safety of our Investigational Medicinal Products (IMPs) throughout their lifecycle.

As a Qualified Person Lead, you will work closely with cross-functional teams to develop and implement effective quality processes and procedures. This includes performing quality assurance activities, providing QP certification, and interacting with external partners and collaborators.

 

About the Role

This is a challenging and rewarding role that requires a strong background in pharmaceutical manufacturing and quality operations. You will be responsible for ensuring compliance with regulatory requirements and standards, including those related to QP certification, GMP, and quality management.

Key responsibilities include:

  • Providing Qualified Person certification for IMPs
  • Ensuring quality oversight and assurance of GMP functions within Pharma R&D
  • Collaborating with external partners and collaborators to reduce regulatory risk

 

Requirements

To succeed in this role, you will need:

  • A science degree and/or QP eligible equivalent degree and extensive experience in pharmaceutical manufacturing and quality operations
  • Eligibility to act as Qualified Person in the EU (Ireland)
  • Broad knowledge of quality management

 

What We Offer

We offer a comprehensive benefits package that includes:

  • Competitive salary and annual bonus
  • Healthcare and wellbeing programmes
  • Pension plan membership
  • Shares and savings programme

 

Why Join Us

We are a dynamic and innovative organization that values diversity, inclusion, and collaboration. If you are passionate about quality, regulatory compliance, and patient safety, we encourage you to apply for this exciting opportunity.

  • Dublin, Dublin City, Ireland TN Ireland Full time

    TN Ireland is a leading Biologics Leader in the North East of Ireland, and we are looking for a highly motivated Head of GMP Compliance to join our team.About the Job:As Head of GMP Compliance, you will oversee the GMP production quality system, ensuring compliance with regulatory and company standards.You will establish effective monitoring structures,...


  • Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Job Role:We are recruiting for an experienced GMP Compliance Professional to join our team in Carlow. As a GMP Compliance Professional, you will be responsible for supporting the Engineering Department in a GMP and Sterile Environment. Your primary objective is to ensure compliance, safety, and reliable supply to our customers. You will conduct...


  • Dublin, Dublin City, Ireland Life Science Recruitment Ltd Full time

    About the Opportunity:This is an excellent position for anyone looking to join a leading multinational who is one of the best at what they do. We are currently recruiting for an exciting opportunity with a pharmaceutical organization based in Tipperary.Key Responsibilities:Support the Engineering Department in a GMP and Sterile Environment.Ensure that...


  • Dublin, Dublin City, Ireland Grifols, S.A Full time

    About This RoleThis QA Packaging Technician role is a key position within our Quality Department, responsible for ensuring GMP Compliance and product release. The successful candidate will be part of a dynamic team supporting packaging operations in Grifols Worldwide Operations Ltd (GWWO). We are seeking an individual with excellent communication skills,...

  • GMP Compliance Expert

    12 hours ago


    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    About the Job DescriptionWe are seeking a skilled GMP Compliance Expert to join our team in Carlow and contribute to the quality of manufactured drug products.The ideal candidate will have a strong understanding of cGMP principles and regulatory requirements and be able to develop and implement effective quality management systems.Conduct regular audits and...

  • GMP Auditor

    2 days ago


    Dublin, Dublin City, Ireland Force Recruitment Full time

    As a GMP Auditor, you will be responsible for conducting audits to ensure that the company's Quality Management System (QMS) is compliant with EU GMP and GDP requirements. You will also be responsible for identifying areas for improvement and implementing corrective actions to maintain compliance.This role involves working closely with cross-functional teams...


  • Dublin, Dublin City, Ireland VALIDATION ASSOCIATES LLC Full time

    About Our ClientOleson is a specialist provider of consultancy and implementation services for IT infrastructure and data architectures within life science manufacturing. We take a full system view, understanding the complex relationships between manufacturing operations, business continuity, IT infrastructure, compliance & change control, and system...

  • GMP Transfer Manager

    12 hours ago


    Dublin, Dublin City, Ireland CareerWise Recruitment Full time

    Job Summary:We are seeking an experienced Technical Transfer Engineer to join our team at CareerWise Recruitment. This is a 12-month contract position that requires strong technical skills and experience in biotechnology.The Job Details:Collaborate with External Partners to achieve business goals and establish a positive working relationship.Manage technical...

  • GMP Compliance Officer

    12 hours ago


    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    LIFE SCIENCE RECRUITMENT IS CURRENTLY SEEKING A QUALITY SPECIALIST WITH EXPERIENCE IN THE PHARMACEUTICAL INDUSTRY.KEY RESPONSIBILITIES:COORDINATE EVENTS AND DEVIATIONSMANAGE BATCH RECORDS DESIGN AND APPROVALCOORDINATE SITE CHANGE CONTROL SYSTEMSAPPROVE VALIDATION PROTOCOLS AND REPORTSREVIEW SOPs/WORK INSTRUCTIONS/FROM OTHER DEPARTMENTSCOORDINATE REGULATORY...


  • Dublin, Dublin City, Ireland TN Ireland Full time

    We are a leading Biologics Leader in the North East of Ireland, and we are looking for a highly skilled GMP Production Specialist to join our team.About the Role:This is an excellent opportunity to work on GMP production quality systems, ensuring compliance with regulatory and company standards.You will establish effective monitoring structures, ensure...

  • GMP Coordinator

    2 hours ago


    Dublin, Dublin City, Ireland TN Ireland Full time

    Social network you want to login/join with:The GMP Coordinator will play the role of assisting in the provision of an efficient and effective cleaning service in accordance with contractual obligations and company policy and standards.Support the day-to-day operations on the ground. Be responsible for the support of GMP and non-GMP Cleaning operatives and...


  • Dublin, Dublin City, Ireland TN Ireland Full time

    PSC Biotech is seeking a highly skilled Process Engineer to join our team at TN Ireland. As a key member of the Process Engineering Group, you will serve as technical support for new product introduction and commercial manufacturing.You will have the opportunity to work with a diverse range of facilities and environments, including biological, chemical,...

  • Compliance Manager

    6 days ago


    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl Healthcare is seeking a highly skilled Compliance Manager to join their team. This role will be responsible for ensuring the quality and compliance of our pharmaceutical products by leading projects related to computer system validation, data integrity, and change control.About the CompanyCpl Healthcare is a global leader in the provision of recruitment...

  • GMP Auditor

    7 days ago


    Dublin, Dublin City, Ireland Grifols, S.A Full time

    Required Skills and QualificationsWe are seeking an experienced professional with a degree in a science, pharmacy, or related discipline. You should have a minimum of 2 years' experience in Quality Systems/Document Control role, with extensive knowledge and understanding of compliance, EU and FDA GMP guidelines. Previous experience in site regulatory audits...


  • Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Job Overview:This exciting opportunity has arisen with an award-winning Pharmaceutical organization based in Ireland. As a Compliance Operations Manager, you will play a key role in driving a safe and compliant culture in our Carlow facility. You will support the Engineering Department in a GMP and Sterile Environment, ensuring compliance, safety, and...


  • Dublin, Dublin City, Ireland Life Science Recruitment Full time

    About the Job:LIFE SCIENCE RECRUITMENT is seeking a skilled GMP Manufacturing Technician to support the development and validation of a manufacturing facility for Commercial Large-Scale Drug Substance.The successful candidate will be responsible for all procedures and processes associated with the manufacture of this drug substance, ensuring compliance with...


  • Dublin, Dublin City, Ireland Orion Engineering Services Limited Full time

    About the CompanyOrion Group Life Sciences is a leading provider of life sciences services, including validation, testing, and consulting. Our team of experts is dedicated to helping our clients achieve compliance and improve their quality management systems.Job DescriptionThe successful candidate will be responsible for supporting several aspects of...


  • Dublin, Dublin City, Ireland Life Science Recruitment Ltd Full time

    Life Science Recruitment Ltd: A Company OverviewIn the life sciences industry, our client is a leading digital therapeutics company that develops innovative solutions for managing injectable medications. Their injection care management system ensures adherence and persistence with medication schedules through reminders, sharps disposal devices, educational...


  • Dublin, Dublin City, Ireland Bausch & Lomb GmbH Full time

    About the RoleThis Quality Assurance Manager position is based in Dublin and offers a hybrid working model.As a key member of our Quality Assurance department, you will be responsible for managing and maintaining our Quality Management System (QMS) and ensuring that it is fit for purpose.Key Accountabilities:Develop and implement quality policies,...


  • Dublin, Dublin City, Ireland Takeda Full time

    Quality Systems and GMP:Proactively participate in auditing programmes as required but particularly in relation to contracted engineering and related services.Notify the Manufacturing Operations Manager/Designee (or other appropriate responsible person) in a timely and comprehensive manner of any deviations from defined manufacturing processes or other...