Associate Director, Compliance & CSV Lead – Hybrid

MSD; Dunboyne; Hybrid; EUR 120,000 - 170,000; Full time

Job summary

MSD in Dunboyne, Co. Meath, seeks an Associate Director of Compliance/CSV Lead to drive validation, regulatory compliance, and audit readiness across the site.

You will lead IT/OT compliance, coordinate with regional teams, manage SDLC controls, and champion data integrity and cyber security within a manufacturing environment. You will collaborate with auditors, improve processes, and ensure conformance with SOPs while guiding cross-functional teams to deliver high-quality biologics

Qualifications

• Bachelor’s degree in a relevant field with strong regulatory exposure.
• Minimum 5 years supporting compliance activities in a regulated setting.
• Knowledge of CFR 21 Part 11, EMEA Annex 11 and related UC compliance.
• Experience managing internal and external audits and inspections.
• Familiarity with ISA S95/S88 in GxP environments.
• Proven ability to validate Cloud, SaaS, and data integration architectures.

Responsibilities

• Lead and/or support site-wide validation and IT/OT compliance initiatives.
• Align regional cross-site activities for CS/CSV compliance.
• Deliver SDLC deliverables, change control, CAPAs, and audits.
• Interact with auditors/agencies and develop audit responses.
• Identify IT/OT compliance risks and remediate them.
• Manage continuous improvement of compliance operations within Automation and IT.
• Report deviations, CAPAs, and performance to quality leadership.

Skills

Regulatory compliance

CSV/QA validation

Audit management

SDLC/IT controls

Data integrity

GxP experience

Risk assessment

Cyber security

SDLC policy knowledge

Cross-site collaboration

Education

Bachelor’s Degree in Computer Science/Engineering/Regulatory compliance

Tools

ISA S95

ISA S88

Cloud/SaaS validation

Data integration platforms

Job description

MSD in Dunboyne, Co. Meath, seeks an Associate Director of Compliance/CSV Lead to drive validation, regulatory compliance, and audit readiness across the site.

You will lead IT/OT compliance, coordinate with regional teams, manage SDLC controls, and champion data integrity and cyber security within a manufacturing environment. You will collaborate with auditors, improve processes, and ensure conformance with SOPs while guiding cross-functional teams to deliver high-quality biologics