Assoc. Director of Compliance - Information Technology - Operational Compliance Lead job at Merck in West Point, PA

Assoc. Director of Compliance - IT/OT Compliance Lead remote type Hybrid locations USA - Pennsylvania - West Point time type Full time job requisition id R378914 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 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. Primary 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. Position Qualifications Education Minimum Requirement: • Bachelor’s degree in computer science, Engineering, Regulatory compliance or a related study Required Experience and Skills: • 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 Experience and Skills: • 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. Required Skills: 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 US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.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. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $139,600.00 - $219,700.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. 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 You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/19/2026 • A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Apply tot his job