MSD Associate Director – Digital & Data Quality Hybrid 

Ireland 

256498354

At our company, we aspire to be the premier research-intensive biopharmaceutical company.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 GMPshopfloor, laboratory, quality system, and infrastructure technology capabilities with quality policies andobjectives.

• 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.

• ontribute to large multifunctional project teams, aligning goals with regulatory expectations and our manufacturing division's qualityobjectives.

• Lead pre-inspection IT readiness and support regulatory inspection and audit activities.

Who You Are

• 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.

• 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.

As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Pleasehesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,