Director Quality Audits

Overview

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.

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.

• 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 time frames.
• 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.

• 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.

• 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…