JOB DESCRIPTION
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.
The senior specialist, Digital Foundational Services, IT / OT Compliance role is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuous maturity to adopt a risk based and lean approach to compliance activities. This role reports into the Director of Compliance for the EMEA / AP region.
Primary Responsibilities:
• Responsible for representing compliance activities to internal and external auditors / agencies
• Supports the development of auditr esponses and engages with local quality organizations on proper strategies when required.
• Responsible for Identifying and engaging 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
• Support local teams with quality and compliance challenges and executions on how to comply with SOPs and or policies
• Responsible for reporting challenges inexecution or adherence to procedural trends due to nonconformance.
• Responsible for reporting status for local / site based deviations / CAPAs and other quality records that will be used as indicators of control and conformance to policy
• Responsible for communication and championing changes to the SDLC policies and procedures at the site
• Responsible to engage as a member of a compliance group that shares knowledge and learnings for better execution and conformance to SOP within Digital. Position Qualifications Education Minimum
Requirement:
•Bachelor’s Degree in Computer Science, Engineering, Regulatory compliance or a related study Required
Experience and Skills:
• 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 ISAS95 and S88 Standards in GxP environment
• Working knowledge of how to validated /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. Preferred Experience and Skills:
• Post Graduate Qualification in Business Strategy or IT architecture
• Prior experience in the pharmaceutical industry, with specific experience in the Manufacturing, Supply Chain, andManufacturing 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 modelling and advanced image analysis.
• Exposure to multiple, diverse technologies and processing environments.
• Knowledge of business process re-engineering principles and processes.
• Strong understanding of application development methodologies.
