Assoc. Dir , Technology Compliance

Merck Gruppe - MSD Sharp & Dohme

Dunboyne

Hybrid

EUR 120,000 - 170,000

Full time

3 days ago

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Job summary

Merck Gruppe - MSD Sharp & Dohme in Dunboyne, Co. Meath, is seeking an Associate Director of Compliance/CSV Lead to oversee computerized system validation and IT/OT compliance across site operations.

The role involves leading cross-functional teams, managing audits, and driving risk-based remediation within a Biologics/Manufacturing context. The incumbent will ensure adherence to 21 CFR Part 11 and ISA/S88 standards, while coordinating with global quality groups and auditors, and guiding SDLC

Qualifications

Bachelor’s degree as listed in the HTML.
5+ years supporting compliance activities.
Knowledge of regulatory requirements (21 CFR Part 11, EMEA Annexes 11).
Ability to manage internal and external auditors/agencies.
Knowledge of ISA S95 and S88 in a GxP environment.
Experience validating Cloud, SaaS, analytics, and data integration platforms.
Understanding of end-to-end manufacturing business processes (Manufacturing, Quality, Supply).
Strong stakeholder collaboration and clear communication across diverse audiences.
Strategic, top-down thinking with ambiguity management.
Experience in Computer Systems Validation, instrumentation/automation, and project management.

Responsibilities

Lead and/or support site functional structures for computerized system validation and IT/OT compliance.
Coordinate regional cross-site alignment for validation and IT/OT compliance.
Ensure supply and quality of all compliance components through planning and SDLC deliverables.
Represent compliance to internal and external auditors/agencies.
Develop audit responses and engage with local quality organizations.
Identify IT/OT compliance risks and remediation.
Perform risk assessments for new technologies or significant changes.
Oversee compliance operations in Automation and IT teams.
Assist local teams with quality and compliance challenges and SOP adherence.
Report deviations and CAPAs; monitor quality records as control indicators.
Communicate SDLC policy changes site-wide and share learnings.

Skills

Regulatory compliance

Auditing

SDLC

Data integrity

Project management

21 CFR Part 11

EMEA Annexes 11

Quality systems

ISA S95/S88

Cloud/SaaS validation

GxP knowledge

Cross-functional collaboration

Communication skills

Strategic thinking

Self-directed leadership

Computer Systems Validation

Education

Bachelor’s Degree in Computer Science/Engineering/Regulatory compliance

Job description

Job Description

A fantastic opportunity has arisen for a Associate Director of Compliance/CSV Lead at our site in Dunboyne, Co. Meath.

Our facility in Dunboyne is a premier, state-of-the‑art facility that enables and advances our best work. By integrating leading‑edge technology with a dynamic, activity‑based workspace, the facility supports seamless connection and collaboration within and across teams and functions. Our Dunboyne facility provides Biologics Drug Substance manufacturing for Clinical Supply, Registration, and Commercial Launch.

Associate Director of Compliance/CSV Lead

Bring energy, knowledge, and innovation to carry out the following:

Lead and/or support various site functional and cross-functional structures for all computerized system validation and IT/OT compliance issues.
Lead and/or support regional cross-site alignment for all computerized system validation and IT/OT compliance issues.
Ensure supply and quality of all compliance components required to deliver high-quality products through tactical planning and execution of project and compliance deliverables, including SDLC deliverables, change-control, periodic reviews, performance monitoring, system administration, access administration, disaster recovery, deviations, incident problem management/investigations, CAPAs, audits, policy deployment, cyber security, data integrity, EHS, training, etc.
Represent compliance activities to internal and external auditors/agencies.
Support the development of audit responses and engage with local quality organizations on proper strategies when required.
Identify and engage in remediation of IT/OT compliance risks.
Execute risk assessments to evaluate the implementation of new technologies or significant changes to existing architectures and technologies.
Accountable for the effective and efficient running of all compliance operations in the Automation and IT teams.
Support local teams with quality and compliance challenges and executions on how to comply with SOPs and/or policies.
Report challenges in execution or adherence to procedural trends due to nonconformance.
Report status for local/site-based deviations/CAPAs and other quality records that will be used as indicators of control and conformance to policy.
Communicate and champion changes to the SDLC policies and procedures at the site.
Engage as a member of a compliance group that shares knowledge and learnings for better execution and conformance to SOP within the Digital Manufacturing Division.
Liaise with Compliance teams from other sites to ensure consistency and best practices applied.

What skills you need

Bachelor’s Degree in Computer Science, Engineering, Regulatory compliance, or a related study.
5+ years supporting compliance activities.
Proficient and demonstrated knowledge of regulatory requirements (21CFR part 11, EMEA Annex’s 11, etc.) that apply to computerized systems validation and compliance for site-based as well as divisional and enterprise systems.
Demonstrated ability to manage internal and external auditors/agencies.
Working knowledge and application of ISA S95 and S88 Standards in GxP environment.
Working knowledge of how to validate/qualify Cloud, SaaS, modern analytics, and data integration architecture platforms and components.
Good understanding of end-to-end Manufacturing business processes and value streams inclusive of Manufacturing, Quality, and Supply chain.
Demonstrated ability to partner with stakeholders and navigate across conflicting priorities to balance critical tactical and strategic needs.
Outstanding written and verbal communication skills – able to effectively communicate complex concepts in simple ways.
Demonstrated ability to effectively collaborate and communicate with a variety of audiences and stakeholders including executive management, business leaders, IT peers, and colleagues worldwide.
Strategic thinker, with demonstrated ability to work in a broad and top-down manner with a fair amount of ambiguity.
Results‑orientation with the proven ability and reputation for developing plans and implementing them successfully.
Self‑directed, self‑motivated, focused leader who with little direction can fill in the gaps as to what is needed, and drive expected results.
Technical, operational, and business expertise in the following disciplines: Computer Systems Validation, Instrumentation/Automation & Control, Project Management.

Prior experience in the pharmaceutical industry, with specific experience in the Manufacturing, Supply Chain, and Manufacturing Quality areas – ideally involving cross‑industry collaboration to drive best practices.
Experience in integrating real‑time shopfloor and lab systems, at an enterprise level, with appropriate levels of resiliency and performance.
Experience in manufacturing analytics systems, including supply and demand forecasting, biologics process modeling, and advanced image analysis.
Exposure to multiple technologies and processing environments.
Knowledge of business process re‑engineering principles and processes.
Strong understanding of application development methodologies.

As a company, we are committed in all that we do. 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. We are proud to be a company that embraces the value of bringing talented, and committed people together. The fastest way to breakthrough innovation is when ideas come together in an inclusive environment

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.

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Required Skills:

Audit Management, Change Management, Code of Federal Regulations Title 21, Computer System Validation (CSV), Data Integrity, Project Management Leadership, Regulatory Compliance, Risk Assessments, Software Development Life Cycle (SDLC), Validation, Verification and Validation (V&V)

Preferred Skills:

Business Processes, Quality Management, Quality Management Systems (QMS)

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift: