International License Partner Quality Specialist

Job Title:      International License Partner Quality Specialist

Reports To:    Associate Director of International Pharma and License Partner Quality

About Lantheus

Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years.

Today, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world.

At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We’re dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress.

Join us and be part of a company where your contributions make a real impact, because we know someone’s health is in our hands.

Summary of role

We are seeking a, International License Partner Quality Specialist, who will be supporting implementation and execution of quality oversight and compliance of International Lantheus license partners manufacturing radiopharmaceuticals.

This position is remote in Europe or the UK and open to applicants authorized to work for any employer within the country they are based in. International travel is expected on case-by-case basis.

Responsibilities

• Collaborate closely with internal Quality teams and International license holders (LH) and contract manufacturers to ensure compliance with applicable GMP, and other regulatory requirements, as well as Lantheus quality standards.
• Support the implementation, operation, and continuous improvement of Lantheus systems and procedures for LH and international contract manufacturer quality management.
• Ensure that international contract manufacturer and LH are quality assessed for suitability and monitored for continuing compliance to applicable GXP regulations and Lantheus requirements, including:
  • Acting as point of contact for quality related aspects.
  • Monitoring quality performance, maintaining oversight trackers, and ensuring timely identification, escalation, and reporting of deviations from approved processes and standards.
  • Support improvement of processes to help maintain required product quality, evaluation of deviations, investigation of out-of-specification results, CAPAs and product complaints as needed.
  • Implementation, management and follow-up of audits at license partners.
  • Negotiation and maintenance of quality assurance agreements.
  • GMP-compliant processing and management of change control requests.
  • Review and approval of plans and reports for the technology transfer to license partners.
• Reporting and correction of deviations from standards in accordance with applicable processes.
• Support in the presentation of quality requirements, e.g., through involvement in the preparation of QA documentation.
• Active participation in discussions on the optimization of processes to efficiently improve the level of quality.
  
  

Qualifications

• Master of Science degree in chemistry, pharmacy or related scientific discipline.
• Minimum of 5 years of experience in regulated, international pharmaceutical manufacturing environment, preferably in radiopharmaceuticals.
• Solid knowledge of international guidelines and quality standards applicable to radiopharmaceuticals (e.g. PIC/s, ICH and WHO).
• Experience working with external partners, license holders, or contract manufacturing organizations.
• Strong communication skills and the ability to collaborate effectively across functions and cultures.
• Sound organizational and project management skills, with the ability to manage multiple activities in parallel.
• Proficiency in Microsoft Office 365 and ability to learn specialized software.
• Fluency in English.

Core Values

The ideal candidate will embody Lantheus core values:

• Let people be their best
• Respect one another and act as one
• Learn, adapt, and win
• Know someone’s health is in our hands
• Own the solution and make it happen

Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until 31 March 2026.

Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. Lantheus is an E-Verify Employer.