Director of Quality Assurance

2 days ago

Cork, Cork, Ireland beBeeValidation Full time €90,000 - €130,000
Quality Assurance Director - Computer Systems

This leadership role will play a critical part in ensuring the quality and regulatory compliance of biopharmaceutical products within our next-generation manufacturing facility.

  • Develop and implement global standards for computer system quality assurance and data integrity.
  • Provide quality direction and governance for QA-owned systems, site IT systems, manufacturing systems, and laboratory systems.
  • Maintain quality assurance procedures, policies, and systems related to data management and CSV.

The successful candidate will work closely with cross-functional teams to support inspections, continuous improvement, and quality culture development at the site and global level.

Key Responsibilities:

Quality Systems and Data Integrity:
  • Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP, data integrity, and other relevant regulations.
  • Ensure accurate documentation of quality records, validation activities, and system-related compliance data.
  • Oversee system change control, deviation management, CAPA, and periodic review processes.
Computer System Validation:
  • Evaluate all GxP computerized systems for CSV requirements and alignment with global standards.
  • Review and approve CSV deliverables, deviations, and risk-based validation strategies.
Regulatory Compliance and Inspection Readiness:
  • Maintain inspection readiness across all supported systems, ensuring alignment with corporate and regulatory standards.
  • Stay current with industry regulations, guidelines, and best practices.
  • Assist in preparing and executing regulatory inspections and audits.
Continuous Improvement and Strategy:
  • Identify areas for optimization in data flow, system integration, and validation strategies.
  • Champion initiatives in digital transformation, data contextualization, and visualization to enhance decision-making and compliance.

  • Quality Assurance Director

    1 week ago

    Cork, Cork, Ireland beBeeAssurance Full time €75,000 - €85,000

    Quality Assurance DirectorOur organization seeks an exceptional Quality Assurance Director to lead the development and implementation of quality management systems across the business.Key Responsibilities:Ensure all operations align with international quality management standards, specifically ISO 9001 and ISO 45001.Develop, implement, and maintain...

  • Director of Quality Assurance

    17 hours ago

    Cork, Cork, Ireland beBeeRegulatory Full time €145,000 - €175,000

    Associate Director Position">We are seeking a skilled and experienced professional to take on the role of Associate Director within our quality assurance team. This leadership position plays a pivotal part in ensuring the highest standards of product quality and regulatory compliance.">The successful candidate will be responsible for implementing global...

  • Quality Assurance Leadership Position

    2 weeks ago

    Cork, Cork, Ireland beBeeQuality Full time €100,000 - €150,000

    Associate Director Job OverviewWe are seeking a highly skilled Associate Director to lead our quality assurance team. The ideal candidate will be responsible for ensuring the highest standards of product quality and compliance.Key Responsibilities:Implement global quality standards at a new site.Provide quality direction and governance for e-systems, IT...

  • Quality Assurance Associate

    3 weeks ago

    Cork, Cork, Ireland Eli Lilly And Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana.Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Quality Assurance Associate

    2 weeks ago

    Cork, Cork, Ireland Eli Lilly And Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana.Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Quality Assurance Associate

    4 weeks ago

    Cork, Cork, Ireland Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Quality Assurance Manager

    4 days ago

    Cork, Cork, Ireland Global Professional Consultants Full time

    Get AI-powered advice on this job and more exclusive features.Global Professional Consultants provided pay rangeThis range is provided by Global Professional Consultants. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay rangeDirect message the job poster from Global Professional ConsultantsMy...

  • Quality Assurance Specialist

    2 weeks ago

    Cork, Cork, Ireland beBeeAudit Full time €40,000 - €60,000

    Quality Assurance ProfessionalWe are seeking a Quality Assurance professional to join our team. As a Quality Assurance professional, you will play a crucial role in ensuring the highest standards of quality in our products.The Quality Assurance professional is responsible for inspecting products, documenting results, and releasing products for customer...

  • Quality Assurance Specialist

    1 week ago

    Cork, Cork, Ireland beBeeQuality Full time €53,000 - €73,000

    Quality Assurance SpecialistAs a Quality Assurance Specialist, you will play a pivotal role in driving quality excellence across operations.

  • Quality Assurance Associate

    1 week ago

    Cork, Cork, Ireland beBeeExpert Full time €40,000 - €60,000

    Quality Assurance ExpertThis is a dynamic and challenging role in our Quality Assurance Department. As a Quality Assurance Expert, you will play a key part in ensuring that we maintain the highest standards of quality in all aspects of our operations.Our ideal candidate will have a strong background in Quality Assurance, with experience in implementing and...