Digital and Data Quality (Snr Specialist)

Job Description

A wonderful opportunity has arisen for a Digital and Data Quality (Snr Specialist) to join the global Digital & Data Quality (DDQ) team in Ballydine, reporting to the Associate Director of DDQ for EMEA.

In this hands-on role, you will support manufacturing, laboratory, and logistics teams to assess, select, and validate computerized systems used in GMP processes, ensuring validation effort matches system complexity and risk. You will provide quality oversight for computerized systems used in support of GMP processes, provide expert Data Integrity (DI) guidance, and support inspection readiness.

At our company, we aspire to be the premier research-intensive pharmaceutical company. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. As a Senior Specialist Digital and Data Quality, you will play a vital role in ensuring compliance with our company’s policies, procedures, and regulatory expectations.

Key Responsibilities

The responsibilities cover the quality aspects of data integrity, GMP computerized systems, master data management, laboratory instrumentation/systems, and supporting infrastructure used in site facilities, utilities, manufacturing, and laboratories to ensure compliance with company policies, procedures, and regulatory expectations.

•Act as a change driver and strategic lead to site processes within the global Quality Management System (QMS) framework.

•Influence the organizational future through review and approval of all quality-related activities, such as policies, procedures, plans, protocols, requirements, reports, deviations, and changes, as well as contributing to site inspection readiness.

•Introduce strategic initiatives on site, driving standardisation across the GMP environment for computerized systems and data integrity, and representing DDQ in global governance meetings for data integrity, computerized system validation, master data management, and lab instrumentation / systems.

•Promote cGMP and Data Integrity awareness and support a culture of continuous improvement. Help develop and maintain training on computerized systems validation, data integrity, and internal procedures.

•Work together with the business to resolve regulatory non-conformances for cGMP computerized systems and data integrity in a way that ensures business efficiency and compliance. Drive improvements on both a local and global level, based on emerging trends, compliance gaps, and system weaknesses.

•Act as a representative for DDQ management in site- and above-site meetings as needed.

Qualifications & Experience

•Bachelor’s degree, preferably in Science, Information Technology, Engineering, or equivalent.

•At least five years of demonstrable experience delivering validated IT solutions or working in an application support role.

•Strong understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH)

•Familiarity or practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or manufacturing environment.

•Strong analytical and problem-solving skills, complemented by strong communication and teamwork skills that add great value to the team’s success.

•Timely decision-making and the ability to manage changing priorities, with strong project management skills, a sense of urgency, and a track record of delivering quality deliverables.

•Extended experience with deviations, CAPA, change control, master data, qualification/validation, and inspection readiness in a GxP environment.

Ballydine is the primary Drug Substance commercialisation hub within the network, where new processes are scaled and transitioned to commercial manufacture. The site supports clinical and commercial API supply and the transfer of processes and technologies across internal manufacturing sites and external partners.

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. So, if you are ready to: Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Additional location(s) Compensation Information:

Required Skills:

cGMP Regulations, Change Management, Deviation Management, Good Automated Manufacturing Practice (GAMP), Manufacturing Quality Control, Pharmaceutical Quality Assurance, Product Disposition, Quality Auditing, Quality Management Standards, Regulatory Compliance, Risk Management, Strategic Planning

Preferred Skills:

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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):

Job Posting End Date:

10/30/2026

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