The Associate Director of Compliance, Digital Foundational Services, IT / OT Compliance Lead for West Point 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 to Foundational Services Compliance USA Regional Lead
• Lead and/or support various site functional and cross functional structures for all computerized system validation and IT/OT compliance issues

Ensure supply and quality of all compliance components required to deliver high quality product through tactical planning and execution of project and compliance deliverables, including SDLC deliverables, change-control, periodic reviews, performance monitoring, system administration, access administration, disaster recovery, deviations, incident problem management/investigations, CAPAs, audits, policy deployment, cyber security, data integrity, EHS, training etc

• Responsible for representing compliance activities to internal and external auditors / agencies
• Supports the development of audit responses 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 in execution or adherence to procedural trends due to nonconformance
• 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 our Manufacturing division

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• Bachelor’s degree in computer science, Engineering, Regulatory compliance or a related study
• 8+ 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
• Working knowledge and application of ISA S95 and S88 Standards in GxP environment
• Working knowledge of how to validated / qualify Cloud, SaaS, modern analytics and data integration architecture platforms and components
• Extensive experience in the implementation and validation of automation systems such as DeltaV DCS, PLC/SCADA, MES and leading of validation teams
• 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

Business Processes, Business Process Modeling, Business Process Re-Engineering (BPR), Compliance Program Development, Computer Science, Control Monitoring, Data Management, Information Security, IT Risk Assessments, IT Risk Governance, IT Risk Response and Reporting, Knowledge of regulations and frameworks, Manufacturing Analytics, Pharmaceutical Management, Policy and process development, Quality Management, Regulatory Compliance, Regulatory Compliance Management, Regulatory Requirements, Risk Assessments, Self Motivation, Stakeholder Management, Technical Advice

$139,600.00 - $219,700.00 An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits

No relocation