Regulatory Quality Systems Expert – GMP Compliance

Msd Ireland; Carlow; Hybrid; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Hybrid work arrangement

Equal opportunity employer

Job summary

MSD Ireland in Carlow is seeking a Quality Systems and Compliance - Regulatory Compliance Specialist to ensure vaccine and biologics manufacturing meet cGMP and regulatory requirements. The role emphasizes data integrity, ALCOA, and site-wide quality governance.

You will manage regulatory dossiers, HPRA notifications, and post-approval changes, while collaborating with site and above-site teams to sustain compliant operations and timely product releases for global markets.

Qualifications

• Bachelor's degree in a science field required or equivalent.
• 5+ years' experience in Regulatory Affairs/QA/Regulatory Compliance in GMP pharma/manufacturing preferred.
• Experience with CMC submissions and health authority Q&A cycles.

Responsibilities

• Ensure CGMP/GDP compliance in day-to-day activities.
• Maintain ALCOA data integrity principles for records and data.
• Prepare GMP dossiers and regulatory submission documents.
• Manage HPRA notifications, site master file, and product renewals.
• Collaborate with cross-functional teams to resolve compliance issues.
• Support audits/inspections and regulatory reporting.

Skills

Regulatory Affairs

Quality Assurance

GMP Knowledge

CMC Submissions

Documentation Management

Change Control

ALCOA Data Integrity

Project Management

Education

Bachelor's degree in a related science

Tools

eCTD Submissions

Document Management Systems

HPRA Portals

Job description

MSD Ireland in Carlow is seeking a Quality Systems and Compliance - Regulatory Compliance Specialist to ensure vaccine and biologics manufacturing meet cGMP and regulatory requirements. The role emphasizes data integrity, ALCOA, and site-wide quality governance.

You will manage regulatory dossiers, HPRA notifications, and post-approval changes, while collaborating with site and above-site teams to sustain compliant operations and timely product releases for global markets.