Knowledge Management Specialist
Johnson & Johnson Innovative Medicine · Raritan, NJ · 2 wk ago
On-siteConsultingFull-time
About the role
Johnson & Johnson Innovative Medicine is seeking a Knowledge Management Specialist to support the development, revision, and implementation of Standard Operating Procedures (SOPs) and develop technical training solutions to maintain operational compliance and capability.
Responsibilities
- Develop, revise, and finalize SOPs to meet regulatory and internal standards; create new SOPs where required.
- Handle SOP revision schedules and ensure timely implementation in line with regulatory requirements.
- Create, develop, and deliver technical, on-the-job, and curriculum-based training programs that support operational and compliance needs.
- Identify training gaps through assessments, audits, and performance reviews; produce targeted training plans and remediation.
- Monitor and evaluate training efficiency and staff proficiency; iterate programs for continuous improvement.
- Define, track, and report training KPIs; develop dashboards and visualizations to communicate performance and trends.
- Support EMFA in the development and execution of Organizational Change Strategy plans (e.g. EMFA Projects), including team member engagement, risk mitigation, and implementation oversight.
- Collaborate cross-functionally to prioritize training and change initiatives based on site objectives and risk assessments.
- Support audit readiness and inspections related to SOPs, training, and change activities.
- Build internal capability by designing training initiatives aligned with site priorities and strategic goals.
- Maintain awareness of industry guidelines, regulatory updates, and modern training methodologies and apply them to program improvements.
- Support investigations and CAPA activities by providing training-related root-cause analysis and corrective action verification.
- Ensure training and SOP documentation practices meet data integrity and record-retention requirements.
Requirements
- Education: Bachelor’s degree or equivalent experience in Life Sciences, Engineering, Business, or related field.
- Required Experience and Skills:
- Minimum 3 years of GxP-regulated experience (biopharmaceutical, cell therapy a plus), with shown experience in SOP management, technical training, or organizational change is a must.
- Showed knowledge of regulatory requirements related to SOPs, training and organizational change.
- Experience supporting change initiatives in regulated environments and familiarity with organizational change methodologies.
- Strong technical writing skills for clear, concise SOPs, training materials, and change documentation.
- Analytical approach with proficiency in data analysis, KPI development, and dashboarding (Power BI or similar).
- Strong project management, interpersonal, and prioritization skills.
- Excellent communication, facilitation, and social skills with the ability to influence cross-functional team members.
- Resilient, adaptable, and proactive in a fast-paced, regulated environment.
- Problem-solving capability: certifications in problem-solving methodologies (e.g., Lean Sigma Green/Black Belt) are a plus.
- Preferred Experience with document control and training management systems.
Qualifications
- May require up to 10% domestic travel.
- Primarily office-based work for training development and documentation; standing/walking required for training delivery and facility walkthroughs.
Benefits
Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits