Senior Specialist, Training Coordination & Compliance Operations

Job DescriptionThe Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for diverse biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.This role will support the Next Generation Biologics (NGB) facility, which will be a premier, state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It can meet all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot scale, small and large scale potent material handling, and the ability to integrate new technologies and cell-line platforms.The Sr. Specialist, Training Coordination, Compliance Operations, is responsible for coordinating GMP training and qualification programs that support personnel qualification and compliance within the NGB facility. The role manages qualification programs, training curricula; administers Learning Management System (LMS) activities, training records, and qualification documentation; coordinates SOP training requirements; and monitors training compliance metrics. In partnership with Operations, Quality, and Subject Matter Experts (SMEs), this position maintains GMP training documentation and ensures personnel are appropriately trained and qualified to perform GMP activities.Job Responsibilities:Coordinate GMP training and qualification programs supporting NGB OperationsPartner with Operations leadership, SMEs, and process owners to establish role-based training and qualification requirementsMonitor training compliance and qualification status, identify gaps, and drive remediation activitiesManage training records and controlled documents in compliance with cGMP, Data Integrity, and Records Management requirementsAdminister and maintain LMS activities, including curriculum management, training assignments, qualification tracking, compliance monitoring, and reportingLead instructor-led training sessions and coordinate onboarding, qualification, and cross-training programsCoordinate and deliver training on GMP and process-related procedures, as applicablePrepare and communicate qualification status reports, compliance metrics, dashboards, and training documentationEvaluate training effectiveness and drive continuous improvement through metrics, performance indicators, and employee feedbackSupport implementation of digital learning technologies and tools that enhance manufacturing operationsServe as a resource for GMP training compliance, qualification programs, documentation practices, and learning systemsRequired Education, Experience and Skills:Education:Bachelor's degree in Biological Sciences, Engineering , or a related discipline with a minimum of 5 years of relevant experience; Master's degree with a minimum of 3 years of relevant experienceExperience & Skills:Supporting GMP training and qualification programs within pharmaceutical, biotechnology, biologics, or other regulated environmentsDeveloping training curricula, qualification programs, and role-based training requirementsCoordinating GMP training programs, qualification management, and curriculum administrationManaging training records, qualification tracking, and compliance reporting within an LMSCoordinating and leading instructor-led, virtual, self-paced, and on-the-job training programsMonitoring training compliance and qualification status and implementing remediation actionsUtilizing training metrics and analytics to monitor compliance and drive continuous improvementManaging controlled training documentation and supporting SOP implementation within GMP quality systemsLeading training-related projects and initiatives from planning through executionSupporting digital learning technologies, electronic work instructions, and training management systemsStrong written, verbal, facilitation, and presentation skillsStrong organizational, planning, and problem-solving skillsAbility to manage multiple projects, priorities, and deadlines in a fast-paced GMP environmentAbility to collaborate across functions and influence stakeholders to achieve business objectivesProficiency in LMS administration, reporting, and compliance trackingKnowledge of cGMP regulations, training compliance requirements, and documentation practicesPreferred Experience and Skills:Developing dashboards and training metrics to monitor compliance, qualification status, and training effectivenessImplementing or supporting digital learning technologies, electronic work instructions, and training management systemsSupporting start-up, commissioning, qualification, technology transfer, or facility expansion activities in a GMP environmentSupporting regulatory inspections and internal audits through training documentation, compliance tracking, and qualification record managementAdvanced data analytics and reporting capabilitiesLearning design and curriculum development capabilitiesChange management and organizational effectiveness skillsContinuous improvement and process optimization methodologiesAbility to leverage digital learning technologies to improve training effectiveness#PRDRequired Skills: Analytical Testing, Analytical Testing, Competency Management, Dashboard Reporting, Data Analysis, Data Reporting, Deviation Management, Document Management, Enterprise Leadership, Equipment Qualification, Good Manufacturing Practices (GMP), Implement Training Programs, Management Development, Metrics Development, Organizational Change Management, Process Design, Process Hazard Analysis (PHA), Process Improvements, Process Optimization, Process Training, Program Administration, Progress Monitoring, Root Cause Analysis (RCA), Technical Writing, Training Coordination {+ 1 more}Preferred Skills: Current Employees apply HERECurrent Contingent Workers apply HEREUS 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.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your RightsEEOC GINA Supplement​We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.Learn more about your rights, including under California, Colorado and other US State ActsThe salary range for this role is$117,000.00 - $184,200.00This 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 OrdinanceLos 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 OrdinanceSearch 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: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Not ApplicableShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:10/3/2026*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. SummaryLocation: USA - New Jersey - RahwayType: Full time