Vice President Quality

ABOUT NUCLEUS RADIOPHARMA

Nucleus RadioPharma is an end-to-end CDMO accelerating radiopharmaceutical therapies through isotope-flexible manufacturing, breakthrough partnerships, and end-to-end innovation that brings complex medicines to patients. We are driven by a vision of a world where every patient with cancer has access to the right therapeutic, at the right time.

POSITION SUMMARY

The Vice President, Quality & Regulatory Affairs at Nucleus RadioPharma is a strategic and hands-on leader responsible for building and scaling a world-class Quality, Regulatory, and Technical Training organization in a dynamic, high-growth CDMO start-up environment. This leader will architect and implement a comprehensive Quality Management System (QMS), global regulatory framework, and GMP Technical Training program from the ground up, ensuring compliance, operational excellence, and workforce readiness. The VP will also ensure the company’s Quality Policy is embedded throughout the organization, driving a culture of accountability, transparency, and patient safety.

Reporting to the Chief Technical and Operations Officer and as a core member of the Operations Leadership Team, this leader will oversee Quality and Regulatory strategy across Manufacturing, Manufacturing Science and Technology (MSAT), and client custom commercialization of innovative radiopharmaceutical products. Responsibilities include establishing regulatory frameworks that support client submissions (IND/CTA/NDA/MAA), ensuring facility and system inspection readiness, scalable systems, and risk-based approaches that align with Nucleus’s growth trajectory.

The ideal candidate is a proven senior executive with deep experience in global radiopharmaceutical or sterile injectable manufacturing operations, capable of establishing infrastructure, processes, and teams that meet the highest standards (FDA, EMA, MHRA, Health Canada, PMDA, and other international agencies). This leader will foster a culture of continuous improvement, lead multi-site quality and regulatory operations, represent Nucleus in regulatory and client engagements, and embed quality into every process, and empower teams to deliver safe, effective, and reliable therapies to patients worldwide.

PRINCIPAL RESPONSIBILITIES

*Strategic Leadership*

• Develop and execute a global Quality and Regulatory strategy aligned with Nucleus RadioPharma’s mission, client commitments, and growth objectives.
• Serve as a key member of the Operations Leadership Team, partnering with the CTOO and executives to align operational priorities with quality, compliance, and patient safety.
• Drive integration of quality and regulatory principles across all phases of product development, manufacturing, and commercialization, ensuring scalability from clinical through commercial readiness.
• Champion a “patient-first” culture where quality, safety, and compliance directly support clinical and operational success.
• Represent Nucleus in client, regulatory, and industry forums to shape strategic quality and regulatory direction.

*Quality Management System (QMS) – Build and Scale*

• Design and implement a comprehensive, phase-appropriate QMS, ensuring alignment with ICH, FDA, EMA, Health Canada, MHRA, and PMDA and other applicable regulations.
• Establish scalable systems, policies, and procedures that support rapid growth while maintaining compliance and inspection readiness.
• Integrate radiopharma-specific requirements including aseptic/sterile operations, radiation safety, and short shelf-life product logistics.
• Implement quality metrics, management review systems, and data-driven continuous improvement initiatives that drive operational excellence and risk-based decision-making throughout the organization.

*Regulatory Affairs Leadership*

• Direct and oversee Nucleus’s global regulatory strategy and submissions (pre-IND, IND, NDA, IMPD, CTA) to ensure timely approvals and efficient product advancement.
• Provide strategic and tactical regulatory support to the R&D Division as well as CDMO clients as requested.
• Build strong, transparent relationships with global health authorities, positioning Nucleus as a trusted and collaborative innovator.
• Anticipate, interpret, and communicate evolving global regulations and radiopharma-specific requirements to ensure compliance and strategic readiness.
• Oversee regulatory planning for new facilities, new product introductions, and eventual post-market activities, ensuring global alignment and inspection preparedness.

*Start-Up and Operational Build-Out*

• Establish all foundational Quality and Regulatory systems, infrastructure, and programs to support a growing, global organization.
• Drive cross-functional execution of start-up activities, from facility qualification to first commercial release and then ensuring readiness for audits and inspections.
• Balance strategic vision with hands-on leadership to deliver results in a dynamic, entrepreneurial environment.

*Cross-Functional Collaboration*

• Partner across R&D, Manufacturing, Supply Chain, Clinical, and Commercial functions to embed quality and compliance into every process and decision.
• Enable speed and innovation without compromising safety or regulatory integrity.
• Act as a trusted advisor and connector between technical operations, business strategy, and patient impact.

*Team Leadership and Culture*

• Build and lead a high-performing global team of Quality and Regulatory professionals.
• Foster a culture of accountability, inclusion, and continuous learning, where every team member understands their role in delivering quality for patients.
• Coach and mentor emerging leaders to support organizational growth and capability.

*Audit, Inspection, and Compliance Excellence*

• Oversee internal and external audits and regulatory inspections across all Nucleus sites and partnerships.
• Ensure all facilities maintain a state of continuous inspection readiness and GMP compliance.
• Lead timely, effective responses to audit findings, ensuring sustainable corrective and preventive actions.

*Vendor and Partner Quality Management*

• Develop and manage robust quality agreements, oversight programs, and performance metrics for external partners and customers.
• Ensure partner operations align with cGMP, GDP, and radiation safety requirements globally.
• Strengthen supplier collaboration through proactive engagement and performance management.

*Training and Organizational Development*

• Lead the cGMP Technical Training organization, establishing a robust, compliant, and scalable training program that ensures 100% adherence to cGMP and radiopharma specific regulatory requirements across all operational areas.
• Implement targeted, role-based training programs to reinforce awareness, competence, and compliance with GMP, quality systems, and radiopharma-specific regulatory standards.
• Develop and maintain a centralized, auditable training management system that ensures documentation, tracking, and verification of all training activities.
• Foster a culture of scientific rigor, data integrity, and right-first-time execution, embedding these principles in every employee’s day-to-day responsibilities.
• Promote company-wide understanding of radiopharma-specific GxP expectations to ensure preparedness for internal audits, external inspections, and regulatory reviews.
• Continuously evaluate training effectiveness through data driven metrics and management review, implementing improvements that strengthen compliance, operational readiness, and organizational excellence.

*Quality Metrics and Reporting*

• Define and monitor key quality and regulatory performance indicators to measure system effectiveness.
• Deliver data-driven insights and recommendations to the CTOO and executive leadership to support decision-making and risk management.
• Use metrics to drive accountability, improvement, and operational transparency.

*Continuous Improvement and Innovation*

• Lead initiatives to enhance processes, reduce risk, and strengthen product quality and compliance.
• Introduce innovative technologies and digital tools to modernize the QMS and streamline operations.
• Drive organizational learning by capturing insights from audits, deviations, and industry trends.

*External Representation and Industry Leadership*

• Represent Nucleus RadioPharma with global regulators, industry associations, and external stakeholders.
• Elevate Nucleus’ reputation as a trusted industry partner and innovator in radiopharmaceutical quality, compliance, and patient focused manufacturing excellence.
• Monitor and anticipate evolving global regulations, technologies, and radiopharma-specific advancements, ensuring Nucleus remains positioned as a leader in innovation, compliance, and operational excellence.

*General*

* Perform other general duties as assigned or directed by supervisors.

QUALIFICATIONS & REQUIREMENTS

*Required (Minimum Qualifications):*

• Education: Bachelor’s degree in Life Sciences, Engineering, or a related field; Master’s or advanced degree preferred.
• Experience: Minimum of 15 years in quality and regulatory affairs within the biopharmaceutical or radiopharmaceutical industry, with at least 12 years in a leadership role.
• Expertise: Deep and broad knowledge of global regulatory requirements (FDA, EMA, Health Canada, PMDA, ICH) and quality systems (21 CFR Parts 210/211/212/820, ISO 13485, ISO 9001, GMP, Annex 1, Annex 2), with proven experience in radiopharmaceutical development, aseptic/sterile manufacturing, radiation safety, and short shelf-life supply chains. Demonstrated ability to design, implement, and scale QMS and regulatory frameworks in start-up and international operations, ensuring inspection readiness, patient safety, and global compliance.
• Leadership: Proven track record of leading cross-functional teams, managing complex projects, and driving organizational change in a startup or high-growth environment. Demonstrated experience in managing teams of analytical, quality and regulatory scientists required.
• Communication Skills: Exceptional verbal and written communication skills, with the ability to interact effectively with internal teams, regulatory agencies, and external partners.
• Analytical Skills: Strong problem-solving abilities, with a data-driven approach to decision-making and continuous improvement.
• Travel: Willingness to travel domestically up to 40% (minimum 6-10 days of travel a month) and internationally as required.

*Knowledge, Skills, and Abilities:*

• Regulatory Knowledge: In-depth understanding of global regulatory frameworks and their application throughout the product development lifecycle.
• Quality Systems Expertise: Experience in developing, implementing, and maintaining QMS in compliance with applicable regulations and standards.
• Risk Management: Ability to identify, assess, and mitigate quality and regulatory 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 environment, demonstrating flexibility and resilience.
• 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 from Rochester, MN, Spring House, PA and other locations. Travel at 50% to all sites is expected.

COMPENSATION & BENEFITS

The salary range for this role is $230,000–$290,000 per year. Please note that compensation may vary outside of this range depending on several factors, including but not limited to a candidate’s qualifications, skills, competencies, and experience.

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 assistance 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.*