IT/OT Compliance Support Lead

Drive Excellence in EMEA as an IT/OT Compliance Support Lead

Are you an experienced professional ready to lead compliance initiatives in the dynamic field of IT and Operational Technology? We are seeking a dedicated and knowledgeable individual to support our regulatory compliance programs across the EMEA region.

If you have a passion for ensuring adherence to policies and procedures while championing continuous improvement, we invite you to apply for this exciting opportunity. Together, we can enhance the quality and safety of our products while navigating the complexities of compliance in a fast-paced environment

Join Our Team as an IT/OT Compliance Support Lead – Drive Excellence in EMEA!

Welcome to the team

Our IT team operates as a Business Partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. In this young and growing team, you will report into the Director of Compliance EMEA.

About the role

The IT/OT Compliance Support Lead EMEA region is charged with the support of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous maturity to adopt a risk based and lean approach to computerized systems compliance activities.

Bring your energy, expertise, and leadership to spearhead our initiatives in computerized system validation and IT/OT compliance. Your role will be pivotal in ensuring our operations meet the highest standards of quality and efficiency. This role may also involve supporting projects on other EMEA sites, requiring occasional travel.

Primary Responsibilities:

• Lead and Collaborate: Drive various site functional and cross-functional teams to tackle all computerized system validation and IT/OT compliance challenges.
• Enhance Digital Validation: Support sites in executing Computerized System Digital Validation SDLC and CSA activities, ensuring robust Computerized System Inventory Management and effective Change and Deviation Management.
• Deliver Quality Compliance: Ensure the supply and quality of compliance components through strategic planning and execution of project deliverables, including SDLC, change control, audits, and cyber security measures.
• Audit Support: Act as a key resource during audits and inspections, representing compliance activities to internal and external auditors/agencies.
• Risk Management: Identify and engage in the remediation of IT/OT compliance risks, supporting risk assessments for new technologies and significant changes.
• Operational Excellence: Facilitate the smooth operation of compliance activities within the Automation and IT teams, addressing quality and compliance challenges effectively.
• Champion Change: Communicate and advocate for updates to SDLC policies and procedures, ensuring alignment with best practices across sites.
• Knowledge Sharing: Collaborate with compliance teams from other sites to foster consistency and share best practices for enhanced execution and adherence to SOPs.

Your profile:

• Bachelor’s degree in Computer Science, Engineering, Regulatory Compliance, or a related field.
• 8+ years in compliance activities, particularly within the pharmaceutical industry, focusing on manufacturing and supply chain.
• Strong knowledge of regulatory requirements (e.g., 21CFR Part 11, GAMP 5) for SDLC and CSA validation.
• Proven ability to manage internal and external auditors and agencies effectively.
• Experience in validating Cloud, SaaS, and data integration platforms, along with knowledge of ISA S95 and S88 standards in GxP environments, Digital validation (eVal) Power user and ServiceNow Data steward.
• Comprehensive understanding of end-to-end manufacturing processes, including quality assurance and supply chain management.
• Exceptional written and verbal communication skills, with the ability to convey complex concepts clearly to diverse stakeholders.
• Self-motivated leader with a results-oriented approach, capable of navigating conflicting priorities and driving successful project outcomes.
• Strong communication skills in English. Dutch and German would also be an advantage.

What we offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits depend on the job location but are in any case very competitive.

For questions about this vacancy

Please send an email including the vacancy number and job title to the following email address: RecruitmentNL@MSD.com

Required Skills:

Computer System Validation (CSV), Lean Six Sigma (LSS), Regulatory Compliance, Secure Software Development Lifecycle, ServiceNow Governance, Risk, and Compliance (GRC), ServiceNow Platform, Software Development Life Cycle (SDLC), Software Development Life Cycle Models, Systems Development Lifecycle (SDLC), Validation

Preferred Skills:

Biotechnology Manufacturing, Pharmaceutical Industry

About Us

We are one company, but we operate under two different corporate brand names. We are known as Merck & Co., Inc., Rahway, NJ, USA in the United States, Canada & Puerto Rico. We are known as MSD everywhere else.