Job Title: Director, Global Training

Reports to: VP | Quality and Regulatory Affairs

Classification: Full Time, Exempt

Work Location: Remote with Travel (estimated 20-30% depending on home-base)

*This position is remote; however, preferred location is the Philadelphia metro area, Minneapolis metro area or Rochester, MN.*

POSITION SUMMARY:

The Director, Global Training at Nucleus RadioPharma is a strategic leader for the design, implementation, and governance of a global, GMP-compliant training and qualification framework in a dynamic, high-growth CDMO start-up environment. This role is accountable for establishing scalable training systems from the ground up and that ensure regulatory compliance, workforce qualification, and inspection readiness across the sites.

Reporting to the VP, Quality and Regulatory Affairs, this role oversees the global training program to ensure personnel are appropriately trained and qualified to perform their assigned GMP responsibilities in compliance with applicable regulatory requirements. The Director is responsible for defining role-based curricula, instructional design principles, and training governance, while partnering with Quality, Operations, and Subject Matter Experts to support effective training delivery and execution. The training program is designed to scale in alignment with Nucleus’ growth trajectory.

The ideal candidate is a proven leader with deep experience in designing and deploying global GMP training programs aligned with global regulatory requirements (FDA, EMA, MHRA, Health Canada, PMDA, and other international agencies). This leader will foster a culture of continuous improvement, provide leadership for multi-site training activities, and represent the Nucleus training program during inspections, audits, and client engagements.

PRINCIPAL RESPONSIBILITIES:

Strategic Leadership

• 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.

Cross-Functional Collaboration

• 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.

Team Leadership and Culture

• 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.

Training and Organizational Development

• Lead the c GMP 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.

Continuous Improvement and Innovation

• 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.

QUALIFICATIONS & REQUIREMENTS:

• Education: Bachelor’s degree in Life Sciences, Engineering, Education, Organizational Development, or a related field required; advanced degree preferred.
• Experience: 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.
• Expertise: 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. Familiarity with additional standards (e.g., Annex 1, Annex 2, ISO-based systems) is preferred.
• Leadership: 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.
• Communication Skills: 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.
• Analytical Skills: Strong problem-solving abilities, with a data-driven approach to evaluating training effectiveness, identifying gaps, and driving continuous improvement.
Travel: Willingness to travel domestically up to 30% and internationally as required to support site readiness, inspections, and major training initiatives.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Learning Management Systems (LMS) Expertise: Experience in developing, implementing, and maintaining a LMS in compliance with applicable regulations and standards.
• Risk Management: Ability to identify, assess, and mitigate risks using industry-standard tools and methodologies.
• Project Management: Skilled in managing multiple projects simultaneously, with a focus on meeting deadlines and achieving objectives.
• Collaboration: Strong interpersonal skills, with the ability to work effectively in cross-functional teams and build consensus among diverse stakeholders.
• Adaptability: 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.
• Ethical Judgment: Commitment to upholding the highest ethical standards and promoting a culture of integrity and accountability.
Work Flexibility: This role will lead a national network of sites including, but not limited to, Rochester, MN, Spring House, PA and Mesa, AZ.

THE FINE PRINT:

Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role are also entitled to paid sick leave and/or other paid time off in compliance with applicable law. Relocation is available to qualified team members.

This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks, and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains “at-will”.

Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

Candidates must be able to successfully complete a pre-employment drug screen, background check, and applicable vision testing. Candidates applying to roles in Manufacturing, Quality Control, Microbiology (Sterility Assurance), MSAT, R&D, and Engineering may require normal near visual acuity (20/20, with or without corrective lenses) and no impairment of color vision, with or without reasonable accommodation.