Specialist, Digital Foundational Services (IT/OT Compliance)

Join our dynamic IT team, where we partner with various departments to propose innovative solutions that enhance organizational capabilities. We work collaboratively across the globe to deliver services that boost productivity and foster innovation.

As a Specialist, Digital Foundational Services focusing on IT and Operational Technology Compliance, you will manage regulatory compliance programs and ensure adherence to policies and procedures. Your role will involve promoting a risk-based and efficient approach to compliance activities.

You will report to the Associate Director of Compliance and collaborate with a cluster lead for the EMEA, Asia-Pacific, or United States region.

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

• Deliver top-tier 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 to maintain the quality of pharmaceuticals.
• 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 as needed.
• 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.
• Communicate and 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.
• 2+ 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.