Associate Director, Quality Control
LantheusAbout the role
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
We are seeking an experienced Associate Director Quality Control (QC) to lead analytical laboratory operations supporting radiopharmaceutical manufacturing and product development at our site in Springfield, NJ. The ideal candidate is a proactive leader with strong technical expertise, comprehensive understanding of industry practices, regulatory requirements, and a commitment to safety, quality and continuous improvement.
This position is based in Springfield, New Jersey and requires a presence on-site. This position is open to applicants authorized to work for any employer within the United States.
Responsibilities
Strategic Leadership & Operational Oversight
- Develop and execute strategic plans for the QC function, leveraging expertise to drive decisions that align with business objectives.
- Manage departmental goals to ensure reliable product supply, adherence to company policies, and successful project execution.
- Oversee budgeting, scheduling, and performance standards to support operational efficiency and compliance.
Laboratory Management
- Ensure all aspects of laboratory operations are effectively managed, including training, scheduling, inventory, equipment maintenance/calibration, and safety.
- Maintain validated methods and qualified equipment, ensuring all QC testing and data management activities comply with SOPs, cGMPs, and regulatory standards.
- Monitor performance metrics and trends to identify opportunities for improvement.
Systems & Technology
- Ensure effective use of electronic systems such as ERP, QMS, LIMS, and lab equipment software.
- Serve as system administrator or alarm notification contact for area-specific software and monitoring systems.
Team Development & Performance
- Develop frontline managers into high-performing leadership teams through active mentorship.
- Build and manage a high-performing team through effective staffing, training, performance reviews, and workload balancing.
- Foster a culture of continuous improvement, compliance, and technical excellence.
- Develop and implement employee development plans to enhance skills, support succession planning, and mitigate operational risks.
Cross-Functional Collaboration
- Act as a liaison with other departments and management levels to support operational decisions and strategic planning.
- Lead team meetings, facilitate VPM efforts, participate in GEMBA walks, and apply Lean/Project Management tools.
Policy & Compliance
- Establish and interpret operating policies and procedures for the QC function.
- Ensure inspection readiness and compliance with global regulatory requirements (e.g., FDA, USP/EP/JP).
- Interface with regulatory inspectors, client and internal auditors, ensuring timely resolution of commitments.
Quality Systems Management
- Oversee timely and effective use of QMS tools including training, investigations, deviations, CAPAs, SOP revisions, change controls, and protocols.
- Serve as lead investigator, SOP owner, change control author, or protocol study lead as needed.
- Resolve complex technical and compliance issues independently, leveraging internal and external expertise.
Safety & Environmental Stewardship
- Promote and enforce safety protocols, ensuring proper use of protective equipment and safe handling of hazardous materials.
- Proactively identify and address safety and environmental risks within the laboratory envir
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