Director Quality Audits

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
This role is responsible for leading Lantheus’ Internal and External Quality Audits team. This role will implement harmonized processes for audits across Lantheus and oversee the execution of internal, external, supplier and clinical audits. Manages and provides direction to team of auditors, ensuring that processes and activities are performed in compliance with company policies, procedures, standards and applicable local, state, federal, and international regulations governing drug products and medical devices. This role will partner with various internal and external cross-functional teams as well as external regulatory and auditing agencies.

This position is based in Bedford, MA and requires a presence on-site of three days per week, and is open to applicants authorized to work for any employer within the United States. Requires approximately 20% travel.

Responsibilities

• Develops and implements a comprehensive audit strategy aligned with organizational goals. Establishes and implements harmonized processes for managing and conducting audits across Lantheus.

• Oversees execution of internal, external, supplier and clinical audits in compliance with policies, procedures, regulatory requirements and industry trends, ensuring adherence to quality standards and regulations. Drives timely completion of corrective actions.
• Responsible for developing, monitoring and reporting audit metrics. Tracks and trends audit observations and drives preventive actions, proactively ensuring potential gaps are mitigated.
• Manages multiple deliverables and projects, realigning resources and priorities to meet challenging timeframes.
• Manages the range of performance management processes for team.
• Contributes to budgetary processes, including efficiency opportunities, in collaboration with leadership. Manages the budget and related activities for the Quality Audit function, and ensures expenditure aligns with approved budget.
• Identifies areas of improvement and leads process improvement initiatives, supporting a LEAN company culture.

 Basic Qualifications

• Bachelor’s degree in a related medical, science or business discipline and minimum 15+ years’ functional experience in Quality, Regulatory or comparable compliance discipline within the pharmaceutical, biopharmaceutical, medical device, or equivalent industries with 10+ years’ of progressive experience in auditing; or equivalent combination of education and experience.
• Strong knowledge of quality management systems (e.g. 21 CFR Part 820, ICH Q10), ICH guidelines, cGxP regulations (e.g. GMP, GCP, GLP, GVP), 21 CFR Parts 11, 210, 211, and 212, and other applicable US and worldwide pharmaceutical regulatory requirements.
• Lead Auditor certification required.
• Demonstrated cross functional leadership skills, with ability to lead and develop teams.

Preferred Qualifications

• Strong planning and project management skills; demonstrated ability to influence and gain commitment from others.
• Excellent verbal, written and presentation skills at all levels both internally and externally, including regulatory bodies as well as customers.
• Must be detail oriented with the ability to multitask and respond to ever changing priorities.
• Ability to work independently, influence with or without authority, facilitate groups with diverse perspectives and bring teams to consensus/alignment.

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 $172,000.00 to $287,000.00 USD 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 February 28, 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].