Senior Specialist, Training Coordination & Compliance Operations

Job description

Job Description The 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 Operations Partner with Operations leadership, SMEs, and process owners to establish role-based training and qualification requirements Monitor training compliance and qualification status, identify gaps, and drive remediation activities Manage training records and controlled documents in compliance with cGMP, Data Integrity, and Records Management requirements Administer and maintain LMS activities, including curriculum management, training assignments, qualification tracking, compliance monitoring, and reporting Lead instructor-led training sessions and coordinate onboarding, qualification, and cross-training programs Coordinate and deliver training on GMP and process-related procedures, as applicable Prepare and communicate qualification status reports, compliance metrics, dashboards, and training documentation Evaluate training effectiveness and drive continuous improvement through metrics, performance indicators, and employee feedback Support implementation of digital learning technologies and tools that enhance manufacturing operations Serve as a resource for GMP training compliance, qualification programs, documentation practices, and learning systems Required 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 experience Experience & Skills: Supporting GMP training and qualification programs within pharmaceutical, biotechnology, biologics, or other regulated environments Developing training curricula, qualification programs, and role-based training requirements Coordinating GMP training programs, qualification management, and curriculum administration Managing training records, qualification tracking, and compliance reporting within an LMS Coordinating and leading instructor-led, virtual, self-paced, and on-the-job training programs Monitoring training compliance and qualification status and implementing remediation actions Utilizing training metrics and analytics to monitor compliance and drive continuous improvement Managing controlled training documentation and supporting SOP implementation within GMP quality systems Leading training-related projects and initiatives from planning through execution Supporting digital learning technologies, electronic work instructions, and training management systems Strong written, verbal, facilitation, and presentation skills Strong organizational, planning, and problem-solving skills Ability to manage multiple projects, priorities, and deadlines in a fast-paced GMP environment Ability to collaborate across functions and influence stakeholders to achieve business objectives Proficiency in LMS administration, reporting, and compliance tracking Knowledge of cGMP regulations, training compliance requirements, and documentation practices Preferred Experience and Skills: Developing dashboards and training metrics to monitor compliance, qualification status, and training effectiveness Implementing or supporting digital learning technologies, electronic work instructions, and training management systems Supporting start-up, commissioning, qualification, technology transfer, or facility expansion activities in a GMP environment Supporting regulatory inspections and internal audits through training documentation, compliance tracking, and qualification record management Advanced data analytics and reporting capabilities Learning design and curriculum development capabilities Change management and organizational effectiveness skills Continuous improvement and process optimization methodologies Ability to leverage digital learning technologies to improve training effectiveness #PRD Required 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 HERE Current Contingent Workers apply HERE 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. 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 Rights EEOC 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