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At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. As an Associate Director Digital and Data Quality, you will play a vital role in ensuring compliance with our company’s policies, procedures, and regulatory expectations.
Your Core Responsibilities
- Provide quality, compliance, and Data Integrity consultancy for computerized systems and supporting infrastructure.
- Align GMP shopfloor, laboratory, quality system, and infrastructure technology capabilities with quality policies and objectives.
- Implement risk-based methodologies for independent quality approval of key qualification/validation documentation to ensure compliance.
- Promote GMP awareness, innovation, and continuous improvement in IT-enabled GMP processes and validation activities.
- Collaborate with stakeholders to assess and select computerized systems for GMP business processes, ensuring technologies meet business needs and encourage innovation.
- Contribute to large multifunctional project teams, aligning goals with regulatory expectations and our manufacturing division's quality objectives.
- Lead pre-inspection IT readiness and support regulatory inspection and audit activities.
Who You Are
You are ready if you have:
- Bachelor’s, Master’s, or PhD in Science, IT, Engineering, Business, or equivalent with relevant years of experience in regulated pharmaceutical manufacturing and delivering validated enterprise systems.
- Direct experience with enterprise systems supporting pharmaceutical manufacturing operations, especially shared systems across multiple legal entities.
- Strong verbal and written communication skills.
- In-depth understanding of current pharmaceutical industry regulations (FDA/EU/ICH), including 21 CFR Part 11, 210, 211, 58, 820, and Data Integrity.
- Extensive knowledge of computerized system validation/compliance principles, theories, and concepts.
- Familiarity with implementing quality systems in pharmaceutical, laboratory, or biotechnology manufacturing environments, and understanding of QRM concepts and Agile Methodologies.
Nice to have, but not essential:
- Professional Certifications like Six Sigma and/or a certification in project management (PMP) and/or Security Awareness.
- Operate as part of a self-directed team in carrying out day-to-day functions and assigning priorities.
