Job Description
An exciting opportunity has arisen for a Senior Quality IT & Data Integrity Specialist to join our Digital and Data Quality team supporting our biologics manufacturing operations in Dunboyne.
You will play a key role in ensuring the integrity and compliance of computerized manufacturing and laboratory systems, with a particular focus on Data Integrity, quality investigations and system lifecycle compliance.
Working as part of an established team, you will partner across Quality, Digital, Engineering and Manufacturing functions to investigate and resolve data-related quality events, maintain systems in a compliant state and support the continued development of a complex biologics manufacturing environment.
Bring energy, knowledge, and innovation to carry out the following:
- Provide quality oversight for Data Integrity and computerized systems across manufacturing and laboratory operations
- Lead and support Data Integrity-related deviations, investigations, root cause analysis and corrective and preventive actions
- Partner with system, process and data owners to ensure computerized systems meet business, quality and regulatory requirements
- Review and approve computerized system validation documentation, system changes, deviations and associated quality records
- Ensure computerized systems remain in a validated and compliant state throughout their lifecycle
- Provide quality oversight for change control, periodic reviews, backup and recovery, incident management and business continuity activities
- Assess Data Integrity risks and ensure effective controls are implemented for electronic records and computerized systems
- Support new systems, validation activities and capital projects from a quality and Data Integrity perspective
- Support regulatory inspections and audits, including the resolution of observations relating to computerized systems and Data Integrity
- Monitor system compliance and performance metrics and communicate risks and priorities to key stakeholders
- Contribute to training and capability building in Data Integrity, computerized systems and regulatory requirements
- Drive continuous improvement across Digital and Data Quality processes and ways of working
What Skills You Will Need
- Strong experience in Data Integrity within a regulated pharmaceutical, biopharmaceutical or healthcare environment
- Experience leading or supporting Data Integrity investigations, deviations and quality events
- Good understanding of computerized systems and computerized system validation principles
- Strong working knowledge of Good Manufacturing Practice and Quality Management Systems, including deviations, change control and corrective and preventive actions
- Experience supporting computerized manufacturing, laboratory or quality systems
- Understanding of Data Integrity principles, electronic records, audit trails and associated regulatory expectations
- Experience within biologics manufacturing is advantageous
- Strong investigation, analytical and problem-solving skills
- Ability to independently manage competing priorities and take ownership of issues through to resolution
- Strong cross-functional communication and stakeholder management skills
- Experience supporting regulatory inspections, audits or inspection readiness activities is advantageous
- Degree in Computer Science, Engineering, Life Sciences, Quality or a related discipline, or equivalent relevant experience
Additional location(s) Compensation Information
Required Skills
Analytical Reasoning, Change Controls, Communication, Computer System Validation (CSV), Cross-Functional Teamwork, Data Integrity, Deviations, GMP Operations, Preventive Action, Problem Solving, Quality Investigations, Quality Management Systems (QMS), Regulatory Inspections, Risk Management, Root Cause Analysis (RCA)
Preferred Skills
Biopharmaceutical Operations
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
Please feel free to speak to us about what flexibility means to you during your application.
So, if you are ready to
Invent solutions to meet unmet healthcare needs, please apply today.
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)
Job Posting End Date
11/29/2026 *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.