Associate Director, Quality Control, NJ site jobs in United States
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Lantheus · 1 week ago

Associate Director, Quality Control, NJ site

Lantheus is a leading radiopharmaceutical-focused company dedicated to improving patient outcomes. They are seeking an experienced Associate Director Quality Control to lead analytical laboratory operations supporting pharmaceutical manufacturing and product development at their Evergreen Theragnostics site in Springfield, NJ.

Health DiagnosticsManufacturingMedical
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H1B Sponsor Likelynote

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
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 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

Qualification

Laboratory ManagementQuality Control OperationsRegulatory ComplianceTeam LeadershipElectronic Systems ProficiencyContinuous ImprovementProject ManagementCommunication SkillsProblem SolvingFlexibility

Required

B.S. in relevant scientific/technical discipline
10 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 and who must be able to lift/move a variety of materials, e.g. portable equipment, lead, gas cylinders, bottles of chemicals, waste containers

Preferred

Advanced degree or technological certificates preferred but not required

Benefits

A 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 generous time off package including paid vacation, holidays, sick days, and paid parental leave.

Company

Lantheus

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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.

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 Company
Total Funding
unknown
2015-06-25IPO

Leadership Team

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Robert Marshall
Chief Financial Officer and Treasurer
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Jamie Spaeth
Chief People Officer
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Company data provided by crunchbase