Senior Technology Compliance Specialist

MSD Malaysia; Dublin; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

MSD Malaysia in Dublin seeks a Senior Technology Compliance Specialist to ensure CSV/SDLC compliance, data integrity, and IT security for biologics manufacturing. The role supports regulatory requirements, audits, and QA processes across the site.

The candidate will liaise with auditors, act as SME for DMO validation, and maintain readiness through reviews and remediation of gaps. A strong IT/compliance background and advanced degree are preferred, with hybrid work arrangements.

Qualifications

• Degree in science, engineering, information technology, or related technical discipline.
• 5–7 years of GxP experience in Computer System Validation (CSV) in life sciences.
• Ability to collaborate across technical, quality, and business functions.
• Strong written and verbal communication to influence stakeholders.
• Experience supporting computerized systems compliance in manufacturing/quality/lab/supply chain.
• Knowledge of automation, instrumentation & control systems, IT compliance, or project management.
• Professional PMP or IT/compliance certifications preferred.
• Experience supporting regulatory inspections and audits.
• SOX IT compliance knowledge.
• Advanced degree in a technical or scientific discipline.

Responsibilities

• Ensure compliance with Global SDLC/CSV, Data Integrity, and IT Security policies and regulatory requirements.
• Plan and execute project and compliance deliverables including change control, periodic reviews, and disaster recovery.
• Maintain and execute compliance activities for computerized systems including CAPAs, audit support, cyber security controls, and training.
• Comply with QMS and standards including EU Annex 11, 21 CFR Part 11, GMP Data Integrity, and SOX requirements.
• Act as a 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 periodic reviews, mock audits, and remediation of gaps.

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

Education

Science, Engineering, IT degree

Master's degree in technical/scientific field

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.

Senior Technology Compliance Specialist

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

Employment Details

• 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 11:59:59 PM 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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.