Senior Technology Compliance Specialist

Merck Gruppe - MSD Sharp & Dohme; Swords; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme in Dublin seeks a Senior Technology Compliance Specialist to support CSV, SDLC, cyber security and data integrity for biologics manufacturing. You will ensure regulatory compliance, manage change control, audits, and validation activities across the DMO team and site operations.

The role requires 5–7 years GxP CSV experience, collaboration across technical and quality functions, and strong communication to influence stakeholders.

Qualifications

• Degree qualification in Science, Engineering, Information Technology, or a related technical discipline.
• 5-7 years GxP experience in Computer System Validation (life science, pharma, medical devices).
• Experience collaborating across technical, quality and business functions in a dynamic environment.
• Knowledge of SDLC, CSV, data integrity, IT compliance and regulatory requirements.

Responsibilities

• Ensure compliance with Global SDLC/CSV, Data Integrity, and IT Security policies, procedures, and regulatory requirements.
• Manage supply of compliance components and deliverables including change control, periodic reviews, access administration, disaster recovery and investigations.
• Coordinate compliance activities for computerized systems: change controls, periodic reviews, access management, disaster recovery, CAPAs, audits, cybersecurity controls, policy deployment, training, and administration.
• Ensure QMS compliance with EU Annex 11, 21 CFR Part 11, SOX and related guidances.
• Act as liaison for auditor requests, documentation management, and inspection tracking.
• Serve as SME for DMO-owned compliance and validation processes, guiding validation strategy and risk management.
• Maintain inspection readiness through mock audits, assessments, and remediation of gaps.

Skills

Audit Management

Change Controls

Collaborative Leadership

Compliance Monitoring

Data Integrity

Data Security

EU Annex 11

SDLC

Policy & Process Development

Stakeholder Management

Validation Processes

Education

Science/Engineering/IT degree

Job description

Job Description

Our Biotech facility in Dublin began construction in 2018 and has progressed at an impressive rate since then. The site plays a pivotal role in the manufacture of our Company's biologics-based medicines, including immuno-oncology, and it has expanded our Company's current internal network of biologics drug substance manufacturing plants since full manufacturing operations began in 2021.

We have a great opportunity for a Senior Technology Compliance Specialist to join our team in Biotech. The Senior Compliance specialist provides IT compliance/validation support to the DMO team and the general site to ensure compliance with Computer Systems Validation (CSV) and Systems Development Lifecycle (SDLC), cyber security and data integrity for the manufacture and supply of quality pharmaceutical products

Bring energy, knowledge, and innovation to carry out the following:

• Ensure compliance with Global SDLC/CSV, Data Integrity, and IT Security policies, procedures, and regulatory requirements.
• Ensure supply of all compliance components required to deliver high-quality product through tactical planning and execution of project and compliance deliverables; including change control, periodic reviews, performance monitoring, system administration, access administration, disaster recovery, deviations, incident problem management/investigations
• Execute and maintain compliance activities for computerized systems, including change controls, periodic reviews, access management, disaster recovery, incident and deviation investigations, CAPAs, audit support, cybersecurity controls, policy deployment, training, and system administration
• Comply with Quality Management system (QMS) with applicable regulations and standards including Computer Systems), EU Annex 11, 21 CFR Part 11, GMP Data Integrity Guidance, and Sarbanes-Oxley (SOX) requirements.
• Act as a key liaison for auditor requests, documentation management, and inspection tracking activities.
• Serve as Subject Matter Expert (SME) for DMO-owned compliance and validation processes, providing guidance on validation strategy, system compliance, and risk management.
• Maintain continuous inspection readiness through periodic reviews, mock audits, compliance assessments, and proactive remediation of identified gaps.

In order to excel in this role, you will more than likely have:

Required

• Degree qualification in Science, Engineering, Information Technology, or a related technical discipline.
• 5-7 years GxP experience in Computer System Validation (life science, pharma, medical devices)
• Demonstrated ability to collaborate effectively across technical, quality, and business functions in a highly dynamic environment.
• Strong verbal and written communication skills with the ability to influence stakeholders at all levels.
• Experience supporting computerized systems compliance activities within manufacturing, quality, laboratory, or supply chain environments.
• Knowledge of one or more of the following areas: Automation, Instrumentation & Control Systems, IT Compliance, or Project Management.

Preferred

• Professional certification in Project Management (PMP) or IT/Compliance-related disciplines.
• Experience supporting or leading regulatory inspections and audits.
• Knowledge of SOX IT compliance requirements.
• Advanced degree (Master's) in a technical or scientific discipline.

We keep patients at the heart of everything we do and are committed to addressing some of the world's most challenging healthcare needs through scientific innovation and operational excellence.As an equal opportunity employer, we value diversity and are committed to fostering an inclusive environment where talented and committed people can thrive and contribute their best work.Should you require support during the recruitment process, please contact the Talent Acquisition Advisor assigned to this role.We are committed to flexible working wherever possible and have introduced a hybrid working model for eligible office-based employees. We encourage candidates to discuss any flexibility requirements during the recruitment process.

Required Skills: Audit Management, Change Controls, Collaborative Leadership, Compliance Monitoring, Data Integrity, Data Security, EU Annex 11, Policy and process development, Software Development Life Cycle (SDLC), Stakeholder Management, Validation Processes

Preferred Skills:

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Current Contingent Workers apply HERE

Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements: Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date: 10/19/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R419370