Nucleus RadioPharma · 15 hours ago
Director, Global Training
United States
Full-time
Remote
Director/Executive
$150K/yr - $200K/yr
10+ years expNucleus RadioPharma is a dynamic, high-growth CDMO start-up that is seeking a Director, Global Training. This role is responsible for the design, implementation, and governance of a global GMP-compliant training framework, ensuring personnel are trained and qualified to meet regulatory requirements.
HealthcareHealth Care
Responsibilities
Develop, maintain, and execute a global GMP Training Program and Qualification strategy aligned with Nucleus RadioPharma’s mission, client commitments, regulatory requirements and growth objectives
Serve as a key member of the Global Quality Team, partnering with site leadership, Operations, and executive leaders to align operational priorities with GMP training, qualification, and inspection readiness initiatives
Champion a 'patient-first' culture where quality, safety, data integrity, and regulatory compliance directly support clinical development and operational success
Partner across GMP functions to define role-based training requirements and ensure training programs meet regulatory, operational, and stakeholder needs
Provide guidance and coaching to GMP functions to ensure training curricula, delivery methods, and qualification requirements support a competent and compliant workforce
Build and lead a high-performing global team of Training professionals
Foster a culture of accountability, inclusion, and continuous learning, ensuring team members understand their role in GMP compliance, data integrity, and product quality
Coach and mentor emerging leaders to support organizational growth and capability
Lead the cGMP Technical Training organization, establishing a robust, compliant, and scalable training framework that supports adherence to applicable cGMP and radiopharmaceutical regulatory requirements across all operational areas
Establish targeted, role-based training and qualification programs that incorporate multiple training modalities, including instructor led training, hands on education of employees (OJT), and assessments, to verify competence beyond 'read and understand' SOP acknowledgement
Ensure the Learning Management System (LMS) functions as a centralized, validated, and auditable training management system supporting documentation, tracking, assessment and verification of training and qualification activities
Embed data integrity and right-first-time principles into training standards and curricula, reinforcing these expectations across GMP roles and responsibilities
Establish and maintain processes to evaluate training effectiveness through defined metrics, trend analysis, and management review and implement improvements to strengthen compliance, operational readiness, and organizational excellence
Oversee the design and governance of new employee onboarding, qualified trainer programs, GMP refresher training, and other training programs, in collaboration with Quality and Operations
Lead continuous improvement initiatives to enhance training processes, reduce compliance risk, and improve training effectiveness
Introduce innovative technologies and digital tools to modernize training development, management, and delivery of training content
Define and monitor training KPIs related to program effectiveness, completion, and qualification, status; report metrics to leadership and ensure appropriate actions are taken to address gaps and improve performance
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, Education, Organizational Development, or a related field required
Minimum of 10-12 years of experience in a GMP-regulated pharmaceutical, biotechnology, or radiopharmaceutical environment, including significant experience designing, implementing, or governing GMP training and qualification programs
Prior leadership experience within Quality, Compliance, Technical Operations, or Training functions is required
Demonstrated knowledge of GMP training and qualification requirements and quality systems, including applicable global regulatory expectations (e.g., FDA, EMA, MHRA, Health Canada, PMDA, ICH) and regulations such as 21 CFR Parts 210, 211, and 212
Proven track record of leading teams in a startup, high-growth, or CDMO environment, with the ability to influence across Quality, Operations, and Technical functions
Exceptional verbal and written communication skills, with the ability to clearly convey training expectations, influence cross-functional stakeholders, and interact effectively with internal teams, regulatory agencies, and external partners
Strong problem-solving abilities, with a data-driven approach to evaluating training effectiveness, identifying gaps, and driving continuous improvement
Willingness to travel domestically up to 30% and internationally as required to support site readiness, inspections, and major training initiatives
Experience in developing, implementing, and maintaining a LMS in compliance with applicable regulations and standards
Ability to identify, assess, and mitigate risks using industry-standard tools and methodologies
Skilled in managing multiple projects simultaneously, with a focus on meeting deadlines and achieving objectives
Strong interpersonal skills, with the ability to work effectively in cross-functional teams and build consensus among diverse stakeholders
Ability to thrive in a dynamic, fast-paced startup and CDMO environment, adapting training systems and priorities in response to evolving regulatory, operational, and business needs
Commitment to upholding the highest ethical standards and promoting a culture of integrity and accountability
Preferred
Advanced degree preferred
Familiarity with additional standards (e.g., Annex 1, Annex 2, ISO-based systems) is preferred
Benefits
Medical, dental, and vision insurance
Health Savings Account or Flexible Spending Account options (depending on the plan chosen)
401k retirement account access with employer matching
Paid sick leave and/or other paid time off in compliance with applicable law
Relocation is available to qualified team members
Company
Nucleus RadioPharma
Nucleus RadioPharma is a new company built to ensure cancer patients can access potentially life-saving radiopharmaceuticals.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$62MKey Investors
Eclipse Ventures,GE HealthcareEclipse Ventures,Mayo Clinic
2024-06-05Series A
2023-10-17Series A· $56M
2022-10-12Seed· $6M
Leadership Team
Stephen Hahn
Chief Executive Officer
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