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Merck · 5 hours ago

Assoc. Director of Compliance - IT/OT Compliance Lead

Lansdale, PA

Full-time

Hybrid

Director/Executive

$140K/yr - $220K/yr

8+ years exp

Merck is a global leader in pharmaceuticals, and they are seeking an Associate Director of Compliance to lead IT/OT compliance initiatives. This role involves managing regulatory compliance programs, supporting audit activities, and ensuring adherence to policies and procedures in a collaborative environment.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

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

Qualification

Regulatory ComplianceCompliance Program DevelopmentRisk AssessmentsComputerized Systems ValidationManufacturing AnalyticsIT Risk GovernanceData ManagementQuality ManagementStakeholder ManagementTechnical AdviceControl MonitoringInformation SecurityPolicyProcess DevelopmentRegulationsRegulatory RequirementsPharmaceutical ManagementSelf Motivation

Required

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

Preferred

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