Associate Director, PET Quality Assurance Operations

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 an Associate Director, PET QA Ops to oversee and continuously enhance our PET QA Operations program, ensuring that systems, processes, and procedures are compliant, harmonized, and optimized to meet regulatory expectations and business objectives.

This is a remote position open to applicants authorized to work for any employer within the United States.

Responsibilities

• Collaborates closely with direct reports and cross‑functional partners, including senior leadership, to ensure Lantheus maintains high‑quality SOPs and processes across the Quality Management System (QMS).
• Plans, organizes, and directs all QA Operations activities related to material release, investigations, change management, metrics, batch record review, Annual Product Report reconciliation, and quality oversight of PET Manufacturing Facility (PMF) operations).
• Develops, maintains, and routinely reviews Supplier Quality procedures to ensure compliance with customer requirements and applicable local, state, federal, and international regulations.
• Oversee supplier performance by maintaining key metrics, analyzing trends, and communicating meaningful insights to senior Lantheus leadership and external suppliers as appropriate.
• Oversee investigations of supplier and manufacturing related issues and ensure timely completion of follow‑up actions and corrective actions to reduce or eliminate defects.
• Identifies, recommends, and implements enhancements to the Supplier Quality Program driven by new regulations, agency guidance, industry standards, emerging technologies, and internal business needs.

Basic Qualifications

• Bachelor’s degree is required in a related medical, science or engineering discipline.
• Minimum of 10 years’ quality assurance / supplier quality engineering experience in a pharmaceutical environment.
• Incumbent must have excellent written, verbal and presentation skills. Must be able to interact effectively with all levels of management.
• Experienced in Positron emission tomography (PET) manufacturing and regulations.
• Must have a good understanding of cGMP requirements by FDA, EMA, and ICH.

Preferred Qualifications

• Experienced in Aseptic manufacturing, including strong technical understanding of aseptic manufacturing processes, equipment and facilities requirements.
• Proficient with Microsoft office applications.
• Excellent oral and written skills.
• Strong attention to detail.
• Black Belt or green belt six sigma / LEAN.
• 10-20% travel if required.

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

The pay range for this position is between $139,000 - $232,000 annually.

Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until March 2, 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.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at [email protected].