Director of Biologics Quality

3 days ago


Dublin, Dublin City, Ireland Blackfield Associates Full time

We are seeking an experienced quality professional to join our client in the role of Quality Director (Biologics QP). This position will be responsible for ensuring the compliant delivery of our client's global programmes by overseeing key external partners and adhering to global regulatory standards.

In this role, you will define and implement a global quality assurance strategy, manage the development and compliance of quality management systems, and oversee quality outputs during programme set-up, including audits, technical agreements, and supplier assessments.

The ideal candidate will have extensive experience as a Qualified Person, with expertise in Biologics, Gene Therapy, or Cryogenic Storage environments. You will possess in-depth knowledge of European Union regulations such as 2001/83/EC, Annex 16, and Good Manufacturing Practice guidelines, and have a strong track record of managing global quality programmes.

Key Responsibilities:

  1. Define and implement a global quality assurance strategy for the global programme team in collaboration with leadership.
  2. Manage the development and compliance of Quality Management Systems for global programme processes.
  3. Oversee quality outputs during programme set-up, including audits, technical agreements, and supplier assessments.
  4. Ensure compliance with Good Manufacturing Practice and Good Distribution Practice regulations for subcontracted facilities.
  5. Support client interactions and resolve packaging, labelling, and regulatory issues.
  6. Lead audits, regulatory inspections, and address any observations.
  7. Develop and manage key performance indicators for external partners and mentor junior team members.

A proven ability to collaborate effectively with cross-functional teams and build relationships with internal and external stakeholders is essential. Flexibility to travel as needed is required.

Seniority Level
  • Director
Employment Type
  • Full-time
Job Function
  • Quality Assurance
  • Industries: Pharmaceutical Manufacturing and Biotechnology Research


  • Dublin, Dublin City, Ireland Blackfield Associates Full time

    We're seeking a highly skilled professional to fill the role of Biologics Quality Director at Blackfield Associates.This position offers a unique opportunity to drive the success of the organisation's global programmes by overseeing key external partners and ensuring compliance with global regulatory standards.About the Role:In this role, you will be...

  • Quality Director

    1 day ago


    Dublin, Dublin City, Ireland Blackfield Associates Full time

    Blackfield Associates is partnering with a leading global healthcare services organisation in the search for a Quality Director (Biologics QP).This pivotal role will ensure the compliant delivery of the organisation's global programmes by overseeing key external partners and ensuring adherence to global regulatory standards.Key Responsibilities (not limited...


  • Dublin, Dublin City, Ireland Blackfield Associates Full time

    At Blackfield Associates, we're partnering with a leading global healthcare services organisation to find a talented professional for the position of Director of Quality Assurance (Biologics QP).This is an exciting opportunity to play a pivotal role in ensuring the compliant delivery of the organisation's global programmes by overseeing key external partners...


  • Dublin, Dublin City, Ireland Director File Full time

    About the RoleThis is an exciting opportunity for a seasoned Financial Services Tax Director to join our team. As a key member, you will be responsible for providing expert financial services tax advice to clients and driving business growth through strategic planning and execution.Key Accountabilities- Develop and maintain strong relationships with clients,...


  • Dublin, Dublin City, Ireland QCS Staffing Full time

    We are looking for a skilled Biological Product Tester to join our team in Dublin. As a key member of our team, you will be responsible for testing biological products to ensure their quality and safety.Key Responsibilities:Data Review: Perform routine data review and analysis to ensure accuracy and completeness.Laboratory Instrumentation: Assist with...


  • Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time

    Bioprocess Lead RoleThis is a great opportunity to take on a senior position within a talented team, driving forward a major project aimed at producing a revolutionary new treatment.The successful candidate will have a strong background in biologic drug substance environments, technical expertise in upstream and/or downstream purification unit operations,...


  • Dublin, Dublin City, Ireland Allergan Full time

    Job Overview:A key leadership role at Allergan, focusing on the overall quality of pharmaceutical products. The successful candidate will lead a team responsible for ensuring the quality and regulatory compliance of AbbVie's products, which include small molecule pharmaceuticals, biologics, and combination products. This involves developing and implementing...


  • Dublin, Dublin City, Ireland WuXi Biologics Group Full time

    A true single-source provider from concept to commercialization for biologics produced from mammalian cell culture.As a QC Separations Scientist, you will be part of various technical projects/activities in the QC Separation group of WuXi Biologics. The site is focused on start-up activities involving commissioning and qualification aligned with project...


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

    As a Senior Biopharmaceutical Specialist, you will play a crucial role in driving innovation and excellence in our organization.Your primary focus will be on serving as a subject matter expert in biologics analytics and characterization, providing technical input to teams and coaching associate staff.Key responsibilities include:Developing and implementing...


  • Dublin, Dublin City, Ireland Blackfield Associates Full time

    As a Quality Director (Biologics QP) at Blackfield Associates, you will play a crucial role in ensuring the compliant delivery of our client's global programmes by overseeing key external partners and adhering to global regulatory standards.You will define and implement a global quality assurance strategy, manage the development and compliance of quality...


  • Dublin, Dublin City, Ireland Blackfield Associates Full time

    We are seeking a highly skilled Quality Director (Biologics QP) to join our team at Blackfield Associates. In this role, you will be responsible for ensuring the compliant delivery of our client's global programmes by overseeing key external partners and adhering to global regulatory standards.As a Quality Director, you will define and implement a global...


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

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...


  • Dublin, Dublin City, Ireland WuXi Biologics Ireland Limited Full time

    Company OverviewAbout WuXi Biologics Ireland LimitedWuXi Biologics is a world-class biologics services provider offering a comprehensive range of solutions from discovery to commercialization. Our mission is to accelerate and transform the development and manufacturing of biologics, enabling clients to bring life-changing therapies to patients worldwide.Job...


  • Dublin, Dublin City, Ireland WuXi Biologics Group Full time

    Senior QA Drug Substance Operations SpecialistIreland Posted 2025-01-13As a Senior QA Drug Substance Operations Specialist, you will be responsible for providing online QA oversight to Drug Substance manufacturing operations in WuXi Biologics in Dundalk, Ireland. This is a crucial role within the Quality organisation with responsibility for directly...


  • Dublin, Dublin City, Ireland Allergan Full time

    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...


  • Dublin, Dublin City, Ireland Allergan Full time

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...


  • Dublin, Dublin City, Ireland WuXi Biologics Group Full time

    A true single-source provider from concept to commercialization for biologics produced from mammalian cell culture.Discover information about the various drug development services we provide for this product type.Recombinant Proteins / Enzymes / Cytokines.High quality, expert services for biologics produced from microbial fermentation.Industry-leading...


  • Dublin, Dublin City, Ireland Director File Full time

    Job OverviewThe Director File is seeking a highly skilled Financial Services Tax Director to join their team. This role will play a crucial part in shaping the organization's financial services tax strategy and providing expert advice to clients.Main Responsibilities- Provide technical financial services tax expertise to clients across various sectors,...

  • Director of Quality

    3 weeks ago


    Dublin, Dublin City, Ireland Cpl Full time

    Director of Quality, Dublin My client, a global pharma company have a new and exciting opportunity for a Director of Quality to join the Dublin site. As the Quality Director for their Dublin site, you are positioned at the heart of their operations, blending site-specific duties with a role on the global quality leadership team. Your position will have...


  • Dublin, Dublin City, Ireland Director File Full time

    Senior Financial Services Tax Consultant NeededWe are seeking a seasoned Financial Services Tax Director to join our team. This role will involve providing expert financial services tax advice to clients, managing multiple projects, and driving business growth through strategic planning and execution.Accountabilities- Develop and maintain strong...