Requisition ID: QUA008461Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.The Associate Director, Quality Management System (QMS) Process Steward is responsible for acting as a cross-functional leader to Simplify, Standardize & Sustain our QMS, for now and the future. The Associate Director will ensure an effective Digital QMS Execution strategy and act as change agent for the Digital QMS Execution strategy, including Merck culture and behavior.The Associate Director is also responsible for ensuring the end-to-end life cycle process for the Digital QMS Execution is well defined per the attributes of a quality system, there is a robust management system in place to monitor the process and that any gaps are identified and managed to completion.Processes are defined with adequate Procedures, Governance, and clear Roles, Responsibilities and AccountabilitiesThe Organization and Infrastructure to support the execution of the processes are defined and installedMetrics are developed for the ongoing evaluation that the system is working as intended, reviewed by the appropriate levels of management, and used as a basis for continual improvement Primary Activities:Provide leadership for the Digital QMS Execution strategy using Nimbus Business Process Modeling for the development, deployment and continuous improvement of QMS Topics across the eight QMS chapters.Upskill Topic Owners in the Nimbus skills required for the development, deployment and maintenance of their QMS Topic.Ensure the Digital QMS Execution processes are effective and efficient, have the correct level of standardization, documentation has the right level of detail to support the compliant, effective, efficient execution of the process, and the impact to the organization and resources is fully understood.Work with Topic Owners and subject matter experts to assess system performance to drive continuous improvement.Help identify, resolve/mitigate or appropriately escalate any issues or delays in content development project execution, and ensure all targets are met on time, in full and to quality.Develop and maintain a robust Management System (Governance/Tier Process) that monitors the process and makes problems visible. Lead development and execution of innovation projects driving operational improvements.Drive best practice sharing and continuous improvements across the MMD network.Consult with the Director of QMS Process Steward on strategic topics and projects, identify areas of focus, define and plan activities, ensure and follow/manage execution along agreed project timelines and deliverables, monitor progress, and take corrective action where necessary.QualificationsEducation Minimum Requirement:Bachelor's Degree in Life Sciences, Computer Science, Engineering, Business or related relevant discipline.Required Experience and Skills:Expertise in the Nimbus Business Process Modeling software, with experience in setting strategy for organizational use.Minimum of 5 years' experience in a regulated environment, preferably in a FDA and/or EU regulated pharmaceutical environment.Preferred Experience and Skills:Lean Six Sigma skills (Green Belt level or higher) or related Merck Production System (MPS) expertise. Minimally must have experience in working with groups in process modeling and improvement. Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites & functions.Excellent facilitation and project management skills, with strong verbal and written communication skills.Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities; effective time management.Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives.Demonstrated ability to make and act on decisions while balancing speed, quality and risk.Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.Capable of working and communicating effectively with all levels of the organization globally.Proven ability to effectively initiate and drive changeYour role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to ...@merck.com.Search Firm Representatives Please Read Carefully:Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.Visa sponsorship is not available for this position.For more information about personal rights under Equal Employment Opportunity, visit:EEOC PosterEEOC GINA SupplementOFCCP EEO SupplementMerck is an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of it's manifestations.Job: Qual Assurance & Ops GenericOther Locations: US; Kenilworth, NJ, US; West Point, PA, US; Rahway, NJ, USEmployee Status: RegularTravel: Yes, 25 % of the TimeNumber of Openings: 1Shift (if applicable):Hazardous Materials:Company Trade Name: Merck
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