Lantheus · 2 days ago
Director Quality Audits
Bedford, MA
Full-time
Hybrid
Director/Executive
$172K/yr - $287K/yr
15+ years expLantheus is a leading radiopharmaceutical-focused company dedicated to improving patient outcomes through innovative science. The Director of Quality Audits will lead the Internal and External Quality Audits team, implementing audit processes and ensuring compliance with regulations while managing a team of auditors.
Health DiagnosticsManufacturingMedical
No H1B
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
Qualification
Required
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
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
Benefits
Comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage
Life and disability benefits
Pre-tax accounts
401(k) with company contribution
Generous time off package including paid vacation, holidays, sick days, and paid parental leave
Company
Lantheus
With more than 65 years of experience in delivering life-changing science, Lantheus is committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2015-06-25IPO
Leadership Team
Robert Marshall
Chief Financial Officer and Treasurer
Jamie Spaeth
Chief People Officer
Recent News
2026-01-03
2025-12-19
Company data provided by crunchbase