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Job Description
An exciting opportunity to join the Ballydine site as a Senior Specialist in IT Compliance. The successful candidate will be computerised systems validation lead for the site. This role will be within the technical unit, ensuring adherence to policies/procedures and driving continuous improvement with a risk-based, lean approach to computerised systems compliance.
Job Description
An exciting opportunity to join the Ballydine site as a Senior Specialist in IT Compliance. The successful candidate will be computerised systems validation lead for the site. This role will be within the technical unit, ensuring adherence to policies/procedures and driving continuous improvement with a risk-based, lean approach to computerised systems compliance.
Key Responsibilities
* Lead/support site and cross-functional teams on computerized system validation and information technology and operational technology (IT/OT) compliance.
* Support Computerized System Digital Validation System Development Lifecycle (SDLC), CSA, Inventory, Change, and Deviation Management.
* Ensure compliance deliverables
* Represent compliance during audits/inspections and develop audit responses.
* Identify and remediate IT/OT compliance risks; support risk assessments for new tech or changes.
* Support compliance operations in Automation and IT teams.
* Assist local teams with quality/compliance challenges and SOP adherence.
* Monitor deviations/CAPAs and communicate SDLC policy changes.
* Collaborate with compliance groups and other sites to share best practices.
Skills & Experience
* Bachelor’s in Computer Science, Engineering, Regulatory Compliance, or related.
* 5+ years in compliance support.
* Strong knowledge of 21CFR Part 11, EMEA Annex 11, GAMP 5
* Experience managing internal/external auditors.
* Understanding of Pharmaceutical Manufacturing, Quality, and Supply Chain processes.
* Strong stakeholder management and communication skills.
* Strategic thinker, results-driven, self-motivated leader.
* Expertise in Computer Systems Validation, Instrumentation/Automation, Project Management.
* Experience with real-time shopfloor/lab systems integration.
* Exposure to diverse technologies and business process re-engineering.
* Lean Six Sigma Green Belt is an advantage.
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Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status
Regular
Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Hybrid
Shift
Valid Driving License
Hazardous Material(s)
Required Skills
Audit Management, Business, Governance Management, IS Audit, Management Process, Quality Assurance (QA), Quality Management, Risk Management, Technical Advice
Preferred Skills
Job Posting End Date
09/5/2025
* 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 R361615
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Information Technology
* Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Veterinary Services
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