Associate Director, Quality Control

Lantheus • Springfield, NJ

21h • $139,000 - $232,000 • Onsite

About The Position

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.

Requirements

• B.S. in relevant scientific/technical discipline
• 12+ years’ experience of progressively more responsible laboratory management in a related scientific/technical discipline or equivalent combination of education and relevant experience in the pharmaceutical industry, related GMP environment, or equivalent.
• Deep understanding of QC operations, regulatory requirements, and industry best practices with proven leadership in managing complex laboratory environments and cross-functional teams.
• Prior direct experience engaging with health authorities is required.
• Recognized as a subject matter expert within the organization, with the ability to solve advanced problems and guide others.
• Flexibility with scheduling requirements for staff and manage support to include evenings, weekends, shifts, and holiday coverage, including during adverse weather conditions.
• Manage and direct staff who work with (or in proximity to) potentially hazardous chemical, radiological, and or biological materials.

Nice To Haves

• advanced degree or technological certificates preferred but not required.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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 environment.

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.

What This Job Offers

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