Associate Director, PET Quality Assurance Operations

Lantheus Brand • Billerica, MA

24d • $139,000 - $232,000 • Remote

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director