Senior Quality Assurance Manager: Data Integrity Specialist

11 hours ago


Limerick, Limerick, Ireland beBeeData Full time €90,000 - €105,000

Our client is a global biopharmaceutical manufacturer seeking an experienced Associate Director to lead site data integrity efforts.

Data Governance
  • Oversight of quality governance for electronic and computerized systems, including MES, Delta V, LIMS, ELN, SAP.
Implementation and Management
  • Lead implementation of data integrity and computer system validation processes.
  • Manage the validation lifecycle, change control, deviations, and CAPAs.
Regulatory Compliance
  • SUPPORT regulatory inspections and maintain inspection readiness.
Training and Development
  • Drive continuous improvement and contribute to global quality strategies.
  • Train and mentor staff in data integrity and CSV best practices.

Requirements:

  • Bachelor's or higher degree in Science, Engineering, Computer Science, or related field.
  • 10+ years of experience in quality/compliance within biopharma or biotech environments.
  • Strong understanding of GMP, CSV (GAMP 5), and global data integrity regulations, including 21 CFR Part 11, Annex 11.
  • Proficiency with lab and manufacturing systems, and validation tools.
  • Excellent leadership, communication, and cross-functional collaboration skills.


  • Limerick, Limerick, Ireland beBeeQuality Full time €98,765 - €123,456

    Job Title: Quality Assurance SpecialistWe are seeking a skilled and detail-oriented Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of product quality and compliance in our electronic systems.Develop, maintain and implement quality assurance procedures,...


  • Limerick, Limerick, Ireland beBeeRegulatory Full time €80,000 - €170,000

    Job Description:    As a key member of the organization, the Quality Assurance Specialist plays a pivotal role in ensuring compliance and integrity of suppliers. This position requires strong collaboration with various teams, including Manufacturing Engineering, Quality Management, Regulatory Compliance, Supply Chain Optimization, Operations Excellence,...


  • Limerick, Limerick, Ireland beBeeCompliance Full time €55,000 - €65,000

    Quality Compliance SpecialistWe are seeking an experienced Quality Compliance Specialist to join our team in Ireland. As a key member of our operations department, you will play a vital role in ensuring the quality and compliance of our construction services.About the RoleThe successful candidate will be responsible for developing and implementing quality...


  • Limerick, Limerick, Ireland beBeeQuality Full time €40,000 - €60,000

    Job Title: Quality Assurance Specialist for Computer SystemsWe are recruiting a skilled professional to join our team in Limerick, Ireland.Main Responsibilities:Ensure the quality of computer systems across all site systemsReview and approve validation documentationDeliver training on computer system qualitySupport maintenance activities for computer...


  • Limerick, Limerick, Ireland beBeeQuality Full time €80,000 - €120,000

    Job Title: Senior Quality EngineerWe are seeking a seasoned quality professional to provide expert engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes.The ideal candidate will be responsible for supporting supplier quality issues impacting daily operations...


  • Limerick, Limerick, Ireland beBeeRegulation Full time €80,000 - €125,000

    Quality Engineer Job OpportunityWe are seeking a Senior Quality Engineer to provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes.The successful candidate will be responsible for supporting supplier quality issues impacting daily operations,...


  • Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

    Within this role you will be responsible for the implementation of data governance (DG) standards, policies and procedures into business operations. You will be a site expert on Data Governance, supporting the Regeneron IOPS Data Governance and Integrity program. In this role, a typical day might include the following: Implementing the Data Governance...


  • Limerick, Limerick, Ireland beBeeQuality Full time €35,000 - €80,000

    Validation and Quality Assurance SpecialistThis is a key role for an experienced professional in equipment validation and quality assurance. As part of our team, you will be responsible for ensuring the highest standards of quality in all aspects of equipment qualification.The successful candidate will have a strong background in quality control and...


  • Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

    Within this role you will be responsible for ensuring that Regeneron's Data Governance systems and practices adhere to the highest regulatory and industry compliance standards.They will provide specialised knowledge and expertise in crafting Data Governance (DG) frameworks, policies, and procedures aligned with regulatory requirements and industry...


  • Limerick, Limerick, Ireland beBeeQuality Full time €45,000 - €55,000

    Quality Assurance ProfessionalThe primary responsibility of this role is to oversee the collection, management and storage of quality control samples within a regulated laboratory environment.Key Responsibilities:Gathering data and documenting test results in compliance with regulatory guidelines.Reviewing test outcomes to ensure conformance to established...