Assoc. Director of Compliance - IT/OT Compliance Lead

Merck•Upper Gwynedd Township, PA

1d•Hybrid

About The Position

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 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.

Requirements

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.

Nice To Haves

Prior experience in the pharmaceutical industry, with specific experience in the Manufacturing, Supply Chain, and Manufacturing 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.

Responsibilities

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.