GxP & PS Compliance Training Manager

GxP & PS Compliance Training Manager

Facility: Quality Location: Plainsboro, NJ, US

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a difference?

The Position

We are seeking a detail-oriented, technically skilled, and passionate Training Manager to join our GxP Compliance & Patient Safety team at Novo Nordisk. This role is responsible for the strategic oversight, administration, governance, and continuous improvement of Novo Nordisk Inc.'s Learning Management System (LMS). This role ensures the LMS effectively supports enterprise learning initiatives, compliance training requirements, and reporting. The Training Manager serves as the primary business owner for LMS operations, partnering closely with Clinical, Regulatory & Medical (CMR), Information Technology (IT), Sales and other business stakeholders to ensure accuracy in training assignments and reporting. This position is responsible for managing LMS configuration, reporting, and training governance processes while ensuring compliance with applicable regulatory and company requirements. The ideal candidate will possess a strong command of pharmaceutical regulations, clinical research processes, and GxP quality management systems, combined with exceptional organizational skills and an unwavering commitment to maintaining the highest standards in a highly regulated environment.

Relationships

This position reports to the Associate Director, GxP Compliance & Patient Safety Training. This role will collaborate cross functionally with Patient Safety, Quality Assurance, Vendor and Contract Management, Information Technology (IT), Finance, and Sales.

The Training Manager will drive and maintain positive rapport and working relationships within and across departments in relation to accurate assignment of training requirements, required quality and regulatory reporting and end user support.

Essential Functions

Key Area 1 | LMS Administration & Operations

Serve as the primary administrator supporting NNI on the enterprise LMS. Administer and maintain the LMS for all NNI training programs, ensuring accurate and up-to-date records of participation and completion. Support the deployment and maintenance of training programs, curricula, and certification requirements. Manage training assignments, learner enrollments, completion tracking, and recurring certification processes. Support internal and external stakeholders with issue resolution in a timely fashion and in a manner which meets their expectations. Generate training reports and analytics to monitor completion rates, training effectiveness, and compliance metrics. Establish and maintain LMS governance standards, processes, and documentation. Ensure system compliance with global policies, audit requirements, and applicable regulatory standards. Support audits and compliance reviews by producing accurate and timely training records. Develop and leverage relationships with HQ SMEs, process management, and system management to influence process and system development in a manner consistent with global / affiliate health authority and/or stakeholder requirements. Provide guidance and/or training to less experienced professionals or support staff. Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation of processes and programs.

Key Area 2 | Curriculum & Assignment Maintenance

Implement job specific training curricula tailored to distinct roles within clinical operations, medical affairs, and regulatory affairs. Manage training assignments encompassing clinical research documentation, regulatory requirements, Good Clinical Practice (GCP), and medical affairs procedures. Partner with Curriculum Managers to implement new curricula and manage updates to existing learning programs, ensuring training requirements are accurately assigned and aligned with role-specific, business, and compliance needs. Actively collaborate with SOP team, Content SMEs, and Curriculum Manager to ensure seamless flow of information and documentation from QualityDocs to LMS, as applicable. Alongside SOP team, Content SME, and Curriculum Manager ensure required training is accurately assigned in LMS. Partner with business stakeholders and Curriculum Manager to develop and maintain curriculum assignment standards, ensuring training requirements are consistently and accurately deployed across the organization. Develop, implement, and maintain governance processes and quality controls to ensure learning curricula are accurately assigned based on role, business function, and compliance requirements.

Key Area 3 | Audit, Inspection & Quality Support

Support internal audits, external inspections, and regulatory inquiries by providing accurate and timely training records, compliance reports, curriculum assignments, and learner completion documentation. Serve as the LMS subject matter expert during audits and inspections, ensuring training data integrity, traceability, and readiness of training documentation. Partner with Quality, Compliance, and business stakeholders to support deviation investigations by providing training records, assignment histories, completion data, and curriculum documentation as needed for root cause analysis. Support the implementation and tracking of Corrective and Preventive Actions (CAPAs) related to training processes, ensuring required training activities, curriculum updates, and assignment changes are completed, documented, and monitored for effectiveness. Conduct periodic reviews and audits of training assignments and records to identify compliance risks, implement corrective actions, and maintain inspection readiness. Maintain documentation and standard operating procedures related to LMS administration and training governance to support regulatory compliance and audit preparedness.

Qualifications

Bachelors degree required; relevant experience may be substituted for degree, when appropriate Requires a minimum of 6 years of progressively responsible, relevant experience; some experience in area of specialty required Ability to work independently with general direction from own manager. Exercises judgment in selecting methods and approaches to assignment. Can plan, schedule, and arrange own activities in accomplishing objective Ability to proactively anticipate multiple deadlines, and drive and manage priorities is required Excellent speaker and/or presentation skills Well-developed interpersonal skills and the ability to interact with staff on all levels and within a culturally diverse environment Excellent project management and organizational skills

The base compensation range for this position is $98,820 to $150,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.