Senior Specialist, Digital Foundational Services (IT/OT Compliance)

Join our collaborative IT team, where we partner with various departments to drive innovation and enhance productivity. We are looking for a Senior Specialist, Digital Foundational Services, focusing on IT and Operational Technology Compliance.

In this role, you will manage regulatory compliance programs, ensuring adherence to policies and procedures while promoting a risk-based and efficient approach to compliance activities. You will report to the Associate Director of Compliance and work closely with a cluster lead for the EMEA, Asia-Pacific, or United States region.

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

• Deliver top-quality computer systems validation for capital projects.
• Promote automation validation standards across projects.
• Collaborate with site compliance and validation teams to coordinate activities.
• Ensure compliance with Computer Systems Validation, Systems Development Lifecycle, Cyber Security, and Data Integrity.
• Act as a Subject Matter Expert on computer validation for capital projects.
• Provide ongoing validation, training, and compliance support.
• Represent compliance activities to internal and external auditors.
• Assist in developing audit responses and engage with local quality organizations.
• Identify and address IT and Operational Technology compliance risks.
• Conduct risk assessments for new technologies or significant changes.
• Support local teams in navigating quality and compliance challenges.
• Report on execution challenges and adherence to procedures.
• Advocate for changes to Systems Development Lifecycle policies and procedures.
• Participate in a compliance group to share knowledge and improve execution.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Bachelor’s Degree in Computer Science, Engineering, Regulatory Compliance, or a related field.
• 5+ years of experience in compliance activities for capital projects.
• Strong knowledge of regulatory requirements related to computerized systems validation.
• Familiarity with ISA S95 and S88 Standards in a Good Practice environment.
• Experience validating and qualifying Cloud, Software as a Service, and data integration platforms.
• Extensive experience with automation systems and leading validation teams.
• Understanding of end-to-end manufacturing processes, including Manufacturing, Quality, and Supply Chain.
• Ability to collaborate with diverse stakeholders and manage conflicting priorities.
• Excellent written and verbal communication skills, with the ability to simplify complex concepts.
• Strategic thinker capable of navigating ambiguity and developing actionable plans.
• Self-motivated leader who can drive results with minimal direction.
• Preferred experience and skills:
• Postgraduate qualification in Business Strategy or IT Architecture.
• Experience in the pharmaceutical industry, particularly in Manufacturing and Supply Chain.
• Knowledge of integrating real-time shop floor and lab systems at an enterprise level.
• Familiarity with manufacturing analytics systems and business process re-engineering principles.
• Travel requirements:
• Willingness to travel 10-25% for assignments outside your primary location, including short-term travel as needed.