Job Description
As a Specialist in Digital Foundational Services, you will play a pivotal role in partnering with various departments to develop innovative solutions that enhance organizational capabilities. You will collaborate across the globe to deliver services that boost productivity and foster innovation.
Your key responsibilities will include managing regulatory compliance programs and ensuring adherence to policies and procedures. You will promote a risk-based and efficient approach to compliance activities, working closely with stakeholders to identify and address IT and Operational Technology compliance risks.
You will report to the Associate Director of Compliance and collaborate with a cluster lead for the EMEA, Asia-Pacific, or United States region. Your expertise will be invaluable in promoting automation validation standards across projects, collaborating with site compliance and validation teams, and ensuring compliance with Computer Systems Validation, Systems Development Lifecycle, Cyber Security, and Data Integrity.
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Required Skills and Qualifications
To excel in this role, you will require:
* 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.
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Benefits
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. We offer a hybrid working model for office-based colleagues around the world, allowing for flexible work arrangements and a better work-life balance.
We strive to find solutions and treatments for some of the world's most challenging healthcare needs. If you are ready to invent solutions to meet unmet healthcare needs, please apply today.
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Others
Employee Status: Regular; Relocation: Not required; VISA Sponsorship: Not provided; Travel Requirements: Flexible; Work Arrangements: Hybrid; Valid Driving License: Required; Hazardous Material(s): None; Required Skills: Audit Management, Business Processes, Business Process Modeling, Business Process Re-Engineering (BPR), Business Strategies, Capital Projects, Clinical Documentation, Compliance Program Development, Computer Science, Emergency Care, Enterprise Systems, Governance Management, Manufacturing Analytics, Occupational Therapy, Quality Assurance (QA), Quality Management, Regulatory Compliance, Regulatory Compliance Management, Risk Management, Systems Development Lifecycle (SDLC), Technical Advice; Preferred 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.