Lantheus · 2 days ago
Associate Director, PET Quality Assurance Operations
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$139K/yr - $232K/yr
10+ years expLantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. The Associate Director, PET QA Ops will oversee and enhance the PET QA Operations program, ensuring compliance with regulatory expectations and business objectives.
Health DiagnosticsManufacturingMedical
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
Qualification
Required
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
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
Benefits
Comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage
Life and disability benefits
Pre-tax accounts
A 401(k) with company contribution
A variety of other benefits
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
H1B Sponsorship
Lantheus has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (9)
2023 (5)
2022 (5)
2021 (1)
2020 (2)
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