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 deliverablesRepresent 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 5Experience 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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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